Yes, I would. I, I think I’m slightly, not cynical, that’s the wrong word, but maybe slightly more pessimistic, or maybe that’s a bit too strong a word, about outcome of things now, and just think, Well, we could take part in something that might show that it’s pointless And, and that’s worthwhile in itself, but not always to think that everything you do is just suddenly going to have this massive knock-on effect in medicine and open lots of doors. Which sometimes things do. But just be a bit more realistic I think or, you know.

It might benefit?

Yes, it might, yes.

And having that explained maybe at the beginning?

Yes. it’s difficult when you’ve never experienced a trial before, isn’t it, to kind of know where things go and how they go and, and, and what they do? But, yes, I think that, that would be helpful to know, you know, Sometimes we don’t find out what we set out to do. Or sometimes we have to stop a trial You know, just, maybe that’s something we could have researched more actually and had a bit of a bigger picture of. You know, you just, and again you just, it’s you and them. Which sounds awful, and that’s not how it should be. And you want to make that gap as small as possible. But it, you know, it puts you at a distance, because actually you, you have no control over it whatsoever. Which comes back to trust again, which I think is, is key. Yes, it’s the key.

If you give advice to other parents based on your experience who maybe wanted to take part in a clinical trial that’s similar, would you, would you be able to do that?

Yes, I would do. I, you know, well, I’d be very hesitant to, well, I would do, but I’d also be hesitant to, because I think your, you know, your individual circumstances and your personality play a huge part. You know, if it was something that was going to worry you or trouble you, then don’t go down the road of doing it, you know. And I think you have to respect, you know, you know, respect where people are in their life situations and everything. But, you know, I feel it’s important and I feel as a society it’s important that we support medical research. it’s hugely important, you know.
And for us looking at the kind of quality of neonatal care and how that’s developed, you know, hugely in the last twenty years and continues to do so in leaps and bounds, I mean, you know, it’s an area of medicine where technology is just expanding and, you know, incredible, I think is really important. And you almost feel like you do have a responsibility, if you can, because that’s how, that’s how it works. So I think it is important to kind of encourage kind of selfless, selflessness really, isn’t it, in potential patients. And I think that’s a really important quality that society somehow ought to nurture. So, yes, you know, in principle I think you should. it’s the individual cost, isn’t it, and working that out. And that’s where the difference is for people. But, but I think a willingness to at least read through some literature and consider it, you know, is something somebody somewhere in a hospital or on a board somewhere should, you know, should be thinking about. And I don’t have the answer of how you do it but, you know, I do think it’s an important attitude.

And what they were interested in was really as a parent, how it, what it feels like, and actually what they can do as staff to ease any anxieties which, which comes about. Now the trial was actually stopped as it happened, so it was actually quite a short period of time that kind of, yes, reading all these emails and things. And I think kind of one of the things that was flagged up then is the confusion of names for parents. You know, it’s meaningless. it’s not meaningless if you’re a medic but, you know, if you’re not it just adds to confusion. One of the big things you talked about was mortality and how you convey, you know, at the end of the day a parent wants to know whether their baby is going to live or die, and, you know, and how you convey and how you use those terms. So, yes, and it was to do with insulin and neonates with a low birth weight in, in different hospitals all around. So, but the doctors, as far as I know, that were heading the trial were all based in [area].

So this is for another trial?

Yes, this is for another trial, which we weren’t part of it. It was just simply whether we’d be a parent representative. Which I think is a really good idea. The downside of it is the meetings are quite long. And I think in this case it was a group of absolutely lovely consultants meeting, who would make you feel incredibly welcome and really value your input. You do it for free, and it has to come at the right period of time when you feel you can do that. But I think it, in essence, it’s a really, really good idea because I think it’s very easy to lose sight, you know. You have all your tables and all your statistics and everything, and that’s how it needs to be of course. But actually there is a parent with a baby at the end of the day, and it’s a personal cost to them, you know. And nobody wants to be a, seemed that they are a set of figures or a box that you can tick. You know, they’re a person. And I think, I think the point we made was, was, was really, it was, it was just trying to encompass parents’ needs. Having said that, the feeling I got from reading through things and certainly talking to my friend who went to more or less every meeting was that people were incredibly thankful for parents who took part and actually had the utmost respect, respect for them. So it wasn’t a thing you did, you know, and it was brushed aside. They, they were absolutely, you know, grateful and, and, and really respected that.

Yes, I think so, yes. And also I think it makes you feel less of an oddity in an area of medicine which is already very specialised. So you’re in the minority anyway, and then you become more in the minority to be eligible for this trial. So, you know, you feel like you’re, you’re dealing in small numbers. Now that might not be the case, but I think it’s quite nice when you feel connected to a wider community or actually, you know, I don’t know, There are a hundred people in the UK doing this trial You know, that, that’s nice.

Yes. I mean my feeling probably is, and I don’t know how right I am, is if you looked at social classes of people who take part in it, I am sure people who are confident and articulate and probably, I’m guessing, fairly well educated are more likely to take part in something. I don’t know what the social spectrum is. I, my guess is if that is the case then there should, somebody, people somewhere should be working really hard at trying to get that group that maybe are less reluctant to for a whole variety of reasons. And that’s where thought and money should be put into.

I think one of the things they talked about a lot was that these things quite often happen at an absolutely crunch, critical time. You know, you have a child, a baby in a neonatal unit. I mean your life quite often is in terms of crisis. How then you begin to make a decision, if you do make a decision, and how best it is to approach parents, and what information you give them and what information you don’t give them. And how much somebody needs to know is probably different to the person in the next cot. And I think also for us a big thing was how much you trusted the doctors. Which sounds an awful thing to say but, you know. And personality plays a part, you know. Is it somebody you like? And you are trusting them with your child’s life you know and you don’t have a choice about it. It’s a choice that’s forced upon you. And I think that has a big part to play. And I think I hinted at that at the beginning on the atmosphere that’s created. Certainly I felt more than happy with the level of care we had, which I think was what has endeared us to kind of be part of things. And, and I’m sure had that not been there then I wouldn’t. But I think trust is a huge thing, you know, a really huge thing, and how doctors build up trust with parents. Which they need to do anyway, but actually if you want a parent to sign a form you’ve got to work twice as hard at it as well.

How they choose to communicate. I, I never felt, I have to say I never felt if I didn’t do the trial we wouldn’t be treated well. I never ever felt that that came in to the equation. And I jolly well hope it wouldn’t. But I never felt that. So I felt we were making a choice. But how freely you make that choice, I’m not sure. Because I think subconsciously

at some level you must surely think, Actually if I agree to this, then I’m being compliant, I’m being a compliant patient, maybe I get better care. And I know it doesn’t work like that, but I’m sure, I, I, you know, I don’t know how free I am from that thought and how much, it, and I think that’s quite a natural thing, isn’t it, you know. Oh, I don’t know, maybe it is for me and my personality. But, you know, if, if you agree to what somebody’s doing, life is going to be better for you. Because generally it is, isn’t it? And I’m not, I really, I really don’t know how much that has a part to play. Even though I’d like to think that for me my choice was entirely rational, I doubt that it was, you know, I really do.

Yes, yes, it was fine. Yes, they do a very nice newsletter, it’s a double-sided newsletter, it’s very easy to read. They’ve worked very hard at making their English very plain and very clear. You know, it is very easy to read. And then you, we got the report at two years and five years. We had that sent to us. And we had a spare copy for the school, the GP, I think. We handed it to the GP who looked slightly bemused as to why she’d been given it. But, yes, and that was very, you know, readable. Everything that they’d done there, the scores, the assessment, you know, very, very clear, very readable and a very accurate picture I would say of kind of where we were really. The communication for the growth hormone is done more when we are in a clinic. I think we have had odd bits through the post. But it has been much more when we’ve been there, This is what we’re finding. This is what we’re looking at. So it’s not, you know, the, I can’t remember the name of the trial, the one we did for sepsis was, you know, very nicely packaged and they’ve worked extremely well, you know, and they do a really good job, you know, at doing that and making that very accessible.

I would actually, to see if it makes interesting reading. And I think it’s important actually to give to my child when he’s old enough to want to have that information, to say, Actually you were part of this. You know, actually it’s your information. Although it’s addressed to me, it’s you, and that’s part of your history and identity. You can then decide to do what you like with it. But, you know, so, yes, it would be.

And I think having things written down is always a nice way to have results, as well as being told things orally, because you come back to them and you reread them and you look at them. And actually sometimes then you might have a question. And so I think you’re more likely to follow something through if something’s written down in a nice, easy to read jolly way.

I think that’s, that’s quite a nice thing to think about, that it is actually your child, this is their results.

Yes, it is, yes, no, definitely. Well, actually what’s interesting was when we had all the scans for him at the hospital, they print out and they give you a copy that they give to the doctors, and actually he’s got them all, I think tucked away in his red little book somewhere, and found it really interesting, I mean to, percentage of body fat and all the rest of it. And, you know, and I feel, well, it’s important though, you know, they are his [results], I was quite kind of pleased that he took them into school. I don’t know what anyone made of them, but he took them into school. And he has asked questions about his blood, you know, Where does it go? Where’s the lab in the hospital? You know all really relevant questions that need to be answered. Because it’s quite a bewildering thing really, Here’s mum and dad. We’re going to sit you in a room and, you know, let some, you know. It is, it’s a difficult thing for a child. And of course you manage it and the hospital manage it and we make it as nice, but you know, those are real questions. Now fortunately for us it, we haven’t, you know, it’s not been too much of a drama. But, you know, it could be, it could be very, very easily, you know. And the other two children have had to watch that as well quite often if childcare has been a bit cobbled together and not there, you know. The, yes, middle child has watched the eldest one having blood taken. You know, and okay that’s fine, you know, but question, you know, you do have to have answers asto, you know, why we do this. And actually we’re doing it for the good of others we think really. You know, it’s a hard thing for a child to understand, you know, it’s very hard. It’s a hard thing for lots of adults to understand but, you know, it’s a hard thing for a child to grasp.

Yes, when there is no immediate benefit?

Absolutely, yes. And also the results for this we might know in two years’ time. Well, two years’ time when you’re a child is just like ages away, isn’t it, you know. So it kind of becomes a little bit meaningless. And I think that worries me a little bit. And, and that certainly would also be another factor why I wouldn’t sign up for anything else. Because I think the timescale for children is just huge. It’s, you know, very hard. And, and it’s your body, it’s, you know, which your parent is giving consent to somebody to do something to. So it is difficult, you know, and it’s very difficult. And I don’t know, you know, there must be ways of making that very appropriate because obviously, you know, trials have to go with any age.

I suppose something that I kind of would want to hit upon, kind of we talked a little bit about financial implications. Obviously you’re not, paid to do a trial and it’s something you do voluntarily. And that’s strange. And I wonder if you were paid to do something, whether that would change your attitude towards doing it, and whether parents should be paid. You know, is it right to be paid to take part?

There is a debate there?

Yes, you know, is that right? And do your motives change? And actually would you get more people signing up? Or would you actually get less, because it’s then perceived to be more riskier if you’re being paid to do something?

That’s the problem.

So, yes, I just think that’s an interesting question. And if we’d been paid to do these things, how, how would it have affected our decision? I think for us it would have been wrong actually. And I think it needs to be something for the trials that we took part in to be done voluntarily. I think it would have been very wrong for money, because the motive becomes wrong and it changes. And also you perceive it to be something that’s risky because you’re being paid to do it. And I think it would be wrong. But I think it’s an interesting question to ask. You know, do you pay somebody for giving their time for something that actually could be hugely important, you know.

What about the young people themselves? Do you think it’s important to pay them?

I almost wonder, yes, I don’t know. Maybe. Yes, I mean maybe for an 18-year-old it is appropriate to be paid to do something. You know, maybe that is hugely important. And it would be interesting to hear what young people have to say about that actually. Because my feeling is that it’s very different and that’s a very different picture. Perhaps it is right, you know, especially if somebody is, has ongoing treatment and it’s something that they’re, you know, commit themselves to doing for x number of years, you know.

We did agree to that with a little bit of reluctance really I think on my part, thinking, Gosh, I, oh, I really don’t know. But we did it for a year. Which meant extra bloods being taken at certain hospital appointments, but they would take blood anyway then. It just meant that they were going to take an extra two; I think it was an extra two vials for their research. And it meant blood pressure being checked more often than they would do normally in the first year. And we had a DEXA scan where they look at your body mass. Now one of the reasons we went ahead with all this is because we live ten minutes away from a major teaching hospital, so actually turning up for appointments and agreeing to these extra things was fairly minimal in terms of effort and getting there. You know, I can park on a friend’s drive and walk with the children and we can play in the park afterwards. I mean for us it’s fairly easy, it’s as easy as it gets really. We’re not travelling miles to, to do anything.

After the first year we then agreed to continue to have extra bloods taken. And also they do this day assessment where your children have to fast and they measure your blood glucose levels, and this extra scan. And we agreed to all that, knowing that we were having more tests than was absolutely necessary, with an overview of, Well, actually it’s going to be of benefit medically in years to come, but there’s actually no benefit for us now because it’s just an extra set of bloods, it’s just an extra test. So we did, we, we’ve done that and we’ve actually decided to stop now. We, we’ve come to the end of that period and they asked if you want to carry on and we’ve said, No; the reason being that our oldest child is eight and he’s at an age where he doesn’t want to have blood taken, and actually now he doesn’t need to have his blood taken. I think it might just be once a year, if that, or something. You know, we’re really down to the minimum, minimum things with the whole, the whole thing. And actually he doesn’t want to. And so that’s fine and I have to respect that.

And it takes time because you have to carve out a day to go into hospital for all these tests to be done. And actually with three children and working it’s slightly more than I kind of feel I’m willing to give. So from a totally selfish point of view I just kind of think, Well, actually, no, we, we, we’ve done that. And there’s a point now where I want to say we’re not going to do any more. And I think it’s mainly because of the discomfort now with an 8-year-old, where actually you have to explain everything to them. You know, You’re giving blood because you know. And that’s a, that’s a hard thing to do. And so we’ve decided no, also what was happening in order to juggle with the childcare and working I think my husband was taking a day off work. And we’ve actually decided that, you know, Okay, we’re going to call it a day and not be of any more help to you. I’m sorry about that. So that’s the growth hormone trial.

Because our child has never caught up in height and weight, we were suitable, should we want, to go ahead with growth hormone treatment, which we opted to. And at that stage, once we said yes, we were then asked whether we’d take part in a clinical trial. Now that, you know, that was a slightly harder decision in many respects to make because it has been costly in terms of time really, which is why we’ve decided not to go any further with it. So our child has growth hormone treatment, treatment which is inject, he’s injected with growth hormone daily to make him grow at a normal rate. And in the first year there’s some uncertainty as to the best dosage, and models are different in America as they are from Europe. So we were part of a trial to see which dose is the best really. Now as it happens we were given the lowest dose, which is great, great for us. And so far it looks like children do very well in their first year on the lowest dose actually and don’t need to be put on a higher dose. So we went into that with a little bit of anticipation because obviously I don’t know what dose before, we, you know, what we were going to be given and I don’t, you know, like most parents you don’t want to inject your child with some synthetic growth hormone if, if you don’t need to.

So that was a little bit more, I can’t quite see the benefit for u but I can see the bigger picture in that, you know, ten years down the line this needs to be more finely tuned as a treatment. And although growth hormone, as far as I understand, has been used in the UK for quite a while, it still, well, certainly it still feels a little bit embryonic at, at times. And, you know, for example the best dose for a 4-year-old isn’t standardised. So that was a bit harder. And we went into it thinking, Well, actually if we’ve signed up to thi which we have, because we signed up to injecting him with growth hormone till he’s 18, it’s, it’s a big commitment

And that was a hard decision to make because the only benefit is that our child is going to grow and not be extremely small in size and height. You know, there’s nothing medically wrong with leaving him small but, you know, we have decided to do it, really from a social point of view. So then to take part in a trial whereby it felt, you know, slightly like these dosage levels have still, you know, still need tweaking and it seems a little bit uncertain was much more, you have to think of a bigger picture as I say. So ten years down the line it will be really nice for children going through this to know, I don’t know, the medium level of, you know, that’s where you need to be or, you know, and for people to have a much bigger picture. And my feeling is, and it might be wrong, there are not that many children, you know, go, you, through the process we have. Most do catch up. So these small for, you know, small for, small for gestational age children, there aren’t that many of them about, although I might be wrong. So actually it’s really important that they try and catch us and get us to be part of it.

And also it’s a day off school, and actually as you get older that starts to matter more, you know. When you’re little and you’re 4 or 5 it, you know, it’s not such a big deal. But actually as you get, you, as you get bigger it, you know, it, it’s a bigger deal. And I think also part of me thinks, you know, our child is fine. He had this very difficult start to life, not that we don’t want to dwell on it, because it’s part of him and it would be wrong to, to write that off, but actually you do need to move on as well and say actually, you know, This is where we are as a family. We do growth hormone. For us it works and it works very well. You know, I would recommend it because it’s worked very well for us. We haven’t had any difficulties at all with it. I, you know, that’s where we are really, you know So it’s a kind of, it’s psychological, you know, We’ve done that. We draw a line, draw a line over it and kind of we move on now really And it is nice not to have hospital appointments hanging over you. When you look in your diary, Oh, right, oka you know to have that kind of freedom is actually, you know, no, it is nice. You do feel quite liberated from, you know, from many clinic appointments.

Was it a relief then when you sort of decided to withdraw?

Yes, oh, gosh, absolutely, yes, yes, yes, yes, yes. Just felt freed, liberated from, two clinic appointments a year, that’s it, that’s fine. And as far as we know it’s all fairly straightforward. There doesn’t seem to have been any problems with the treatment. So, you know that’s it. Yes, liberated from, yes, from it all, yes. Really nice feeling, yes.

After the first year we then agreed to continue to have extra bloods taken. And also they do this day assessment where your children have to fast and they measure your blood glucose levels, and this extra scan. And we agreed to all that, knowing that we were having more tests than was absolutely necessary, with an overview of, Well, actually it’s going to be of benefit medically in years to come, but there’s actually no benefit for us no because it’s just an extra set of bloods, it’s just an extra test. So we did, we’ve done that and we’ve actually decided to stop now. We, we’ve come to the end of that period and they asked if you want to carry on and we’ve said, N; the reason being that our oldest child is eight and he’s at an age where he doesn’t want to have blood taken, and actually now he doesn’t need to have his blood taken. I think it might just be once a year, if that, or something. You know, we’re really down to the minimum, minimum things with the whole, the whole thing. And actually he doesn’t want to. And so that’s fine and I have to respect that.

And it takes time because you have to carve out a day to go into hospital for all these tests to be done. And actually with three children and working it’s slightly more than I kind of feel I’m willing to give. So from a totally selfish point of view I just kind of think, Well, actually, no, we’ve done that And there’s a point now where I want to say we’re not going to do any more. And I think it’s mainly because of the discomfort now with an 8-year-old, where actually you have to explain everything to them. You know, You’re giving blood becauserdquo; you know. And that’s a hard thing to do. And so we’ve decided no, also what was happening in order to juggle with the childcare and working I think my husband was taking a day off work. And we’ve actually decided that, you know, Okay, we’re going to call it a day and not be of any more help to you. I’m sorry about that So that’s the growth hormone trial.

It was just this one nurse who followed it through, who we felt we got to know a bit. And now we’re not part of the trial she’s disappeared. So that slightly feels a little bit odd really because it kind of feels, Well, you know, bye-bye But, yes, no, that was fine. She was persistent and the hospital were persistent as well. And when we saw the consultant at clinic she, they always talked about the trial and even when we were on it they would thank you very much for your help and just say how useful it is and, you know. So I certainly didn’t feel it was something we were kind of brushed to one side with. It felt, you know, that it was important to them and they wanted us to realise how important it was. And they would take time to thank you and do it very well, you know, and do it very appropriately and, and, and very nicely. So we were quite well looked after by the hospital. You know, the cost to us was time and I would say discomfort to my child. And there comes a point where you think, Actually we don’t need to do this. We, you know, life is hard enough sometimes with small children without kind of adding, you know, adding to i which was really my thought.

And also it’s a day off school, and actually as you get older that starts to matter more, you know. When you’re little and you’re 4 or 5 it, you know, it’s not such a big deal. But actually as you get, you, as you get bigger it, you know, it, it’s a bigger, it’s a bigger deal. And I think also part of me thinks, you know, our child is fine. He had this very difficult start to life, not that we don’t want to dwell on it, because it’s part of him and it would be wrong to, to write that off, but actually you do need to move on as well and say actually, you know, This is where we are as a family. We do growth hormone. For us it works and it works very well. You know, I would recommend it because it’s worked very well for us. We haven’t had any difficulties at all with it. I, you know, that’s where we are really, you know. So it’s a kind of, it’s psychological, you know, We’ve done that. We draw a line, draw a line over it and kind of we move on now really. And it is nice not to have hospital appointments hanging over you. When you look in your diary, Oh, right, okay you know, to have that kind of freedom is actually, you know, no, it is nice. You do feel quite liberated from, you know, from many clinic appointments.

I think that’s, that’s quite a nice thing to think about, that it is actually your child, this is their results.
Yes, it is, yes, no, definitely. Well, actually what’s interesting was when we had all the scans for him at the hospital, they print out and they give you a copy that they give to the doctors, and actually he’s got them all, I think tucked away in his red little book somewhere, and found it really interesting, I mean to, percentage of body fat and all the rest of it. And, you know, and I feel, well, it’s important though, you know, they are his [results] I was quite kind of pleased that he took them into school. I don’t know what anyone made of them, but he took them into school. And he has asked questions about his blood, you know, Where does it go? Where’s the lab in the hospital You know all really relevant questions that need to be answered. Because it’s quite a bewildering thing really, Here’s mum and dad. We’re going to sit you in a room and, you know, let some, you know It is, it’s a difficult thing for a child. And of course you manage it and the hospital manage it and we make it as nice, but you know those are real questions. Now fortunately for us it, we haven’t, you know, it’s not been too much of a drama. But, you know, it could be, it could be very, very easily, you know. And the other two children have had to watch that as well quite often if childcare has been a bit cobbled together and not there, you know. The, yes, middle child has watched the eldest one having blood taken. You know, and okay that’s fine, you know, but question, you know, you do have to have answers as to, you know, why we do this. And actually we’re doing it for the good of others we think really. You know, it’s a hard thing for a child to understand, you know, it’s very hard. it’s a hard thing for lots of adults to understand but, you know, it’s a hard, it’s a hard thing for a child to, to grasp.

Yes, I would actually, to see if it makes interesting reading. And I think it’s important actually to give to my child when he’s old enough to want to have that information, to say, Actually you were part of this. You know, actually it’s your information. Although it’s addressed to me, it’s you, and that’s part of your history and identity. You can then decide to do what you like with it But, you know, so, yes, it would be.

And then we got the results of those all printed out and all written up and posted to us. We had copies to give to our GP. And then the trial itself, they were brilliant at communicating actually. So you get, I think kind of two, yes, probably every six months a newsletter comes out, you know, about the number of people who’ve been recruited, what’s going on, what they thinks’ happening. They even send us Christmas cards I do believe. I think they might have stopped that now. But it, it was, the communication, you know, was really very good. And actually what they found with the antibiotics is that it doesn’t make any difference whatsoever. So that antibiotic is not going to be used in neonatal medicine. So that was quite surprising actually, because that wasn’t what we’d been led to believe. So that’s quite an interesting turn on, you know, why you need clinical trials actually to, even though everyone had a good feeling and it had been very successful in paediatric medicine, for, for neonates that wasn’t applicable. So that was quite interesting. So we had the antibiotics for nothing. But never mind. I’ll put that down to, that’s just the way it goes. That was the purpose of it.

Well, I did feel a bit kind of, I suppose a bit let down actually, because it had been such a positive thing. And I think when you’ve had a very difficult birth story or an unusual birth story or something that’s gone very wrong or something that’s not gone to plan, I think it takes a long time, if you ever do, to completely recover from that. So I think I remember a lot more and conversations and things, whereas with my other children I probably don’t have that. So, yes, you kind of can, I can remember very much people saying, you know, I remember the registrar saying, you know, That’s brilliant. He’s been picked. That’s fine, that’s great. You can start the antibiotics tonight you know. And, you know, all being very positive. And, and in a very drastic situation, when hospital staff are positive, that gives you hope as well, you know.

So we get our car parking fees back, which they did very, well the cheque always arrived in the post very quickly. Obviously compensating you in terms of time is slightly harder to, to quantify. And I guess like many parents you do give up chunk, chunks of your time. And I guess we’re not the only people who, you know, who would, who would say that at all, you know. You do very willingly give up big parts of your day and reorganise your day. But the bigger picture is down the line. it’s not immediately here in front of us. And so I think you have to keep that in mind and think, Well, the treatment we’ve got actually, if somebody hadn’t been pioneering and been willing to have done this ten years ago, well, we wouldn’t be here no you know. And that’s very much how it seems to work.

And when our eldest child was born there were a number of complications in the pregnancy, and our eldest child ended up being delivered at 30 weeks with a very low birth weight. So he was less than a kilo. And because of that we spent quite a long time in a neonatal unit and also in a paediatric ward, and we became suitable and eligible for a, a number of clinical trials. The first trial we were, the first trial we were offered was a trial to do with ventilators, in that because our baby was going to be very preterm and growth had stopped in pregnancy, it would seem very likely that when they delivered him he was going to need to be put on a ventilator. So we were signed up for a trial to do with types of ventilators. We were given quite a lot of information in a very short space of time which was all right. The consultant who was heading it up was absolutely lovely, made himself very available so we could ask him about lots of questions, but actually answered I think a lot of our questions, and was very reassuring that it was all kind of run-of-the-mill stuff for them. It wasn’t anything out of the ordinary. It was simply to do with one machine versus another and they just wanted to, to look at that. So we signed up and said, Yes, that’s absolutely fine On reflection it was, you know, an incredibly difficult time. I had a, a very high-risk pregnancy and I was also losing a lot of blood as well as the, the problem of the baby not growing. So I actually did leave a lot of decisions to my husband. I wasn’t really in a fit state to be able to do very much. However I do feel happy that we agreed to do this. The slight problem was when our child was born he was breathing unaided, so we didn’t need to be part of the trial. So we’d had kind of a lot of information to think about and then suddenly we weren’t at the ventilating stage at all. So that was the first trial, we were happy to be part of but actually we weren’t needed. So everyone kind of went away.

You know, for me a decision I never made it alone; I made it with my husband. I think if I’d had to make it alone, I would have had to have, call on friends, you know, who are academics, you know, who, who do this professionally for a living, to say, you know, Is, is this okay you know, Is what I’m signing up to all right And I think definitely I needed to have backing of somebody behind me to feel confident and comfortable in my decision. It wasn’t something I could do by myself. And I think, I don’t know if we, yes, I, you know, I think the hospitals do encourage that really, is, you know, is a joint decision, not something you make lightly and not something that you make by yourself, but it’s something you make with somebody. And actually you’re making it for the interests of your child as well, you know. There’s a third party involved. And that’s I think, you know.

I think that’s the, sort of the interesting bit, isn’t it? Because when it’s for yourself it’s kind of, it’s a different process.

Oh, definitely a different process, yes. And it’s, it’s far harder when you’re taking on somebody else, when they can’t sometimes articulate or communicate that to you, and it’s far harder.

Yes, yes. it’s that feeling that this is all kind of at a developing stage. Which is slightly unnerving to a patient, I have to say. You do feel slightly unnerved, especially when it’s for your child, not to you. I think if it was for myself, that’s fine. But I think, you know, for any parent, when it’s their child, the maternal instinct to protect no matter at what cost you kind of almost have to override I think. And that’s hard to do. And my guess is that’s why lots of people don’t sign up to things, yes.

I think one of the things they talked about a lot was that these things quite often happen at an absolutely crunch, critical time. You know, you have a child, a baby in a neonatal unit. I mean your life quite often is in terms of crisis. How then you begin to make a decision, if you do make a decision, and how best it is to approach parents, and what information you give them and what information you don’t give them. And how much somebody needs to know is probably different to the person in the next cot. And I think also for us a big thing was how much you trusted the doctors. Which sounds an awful thing to say but, you know. And personality plays a part, you know. Is it somebody you like? And you are trusting them with your child’s life, you know, and you don’t have a choice about it. it’s a choice that’s forced upon you. And I think that has a big part to play. And I think I hinted at that at the beginning on the atmosphere that’s created. Certainly I felt more than happy with the level of care we had, which I think was what has endeared us to kind of be part of things. And, and I’m sure had that not been there then I wouldn’t. But I think trust is a huge thing, you know, a really huge thing, and how doctors build up trust with parents. Which they need to do anyway, but actually if you want a parent to sign a form you’ve got to work twice as hard at it as well.

How they choose to communicate. I never felt, I have to say, I never felt if I didn’t do the trial we wouldn’t be treated well. I never ever felt that that came in to the equation. And I jolly well hope it wouldn’t. But I, I never felt that. So I felt we were making a choice. But how freely you make that choice, I’m not sure. Because I think subconsciously

at some level you must surely think, Actually if I agree to this, then I’m being compliant, I’m being a compliant patient, maybe I get better care And I know it doesn’t work like that, but I’m sure, I you know, I don’t know how free I am from that thought and how much, it, and I think that’s quite a natural thing, isn’t it, you know. Oh, I don’t know, maybe it is for me and my personality. But, you know, if, if you agree to what somebody’s doing, life is going to be better for you. Because generally it is, isn’t it? And I’m not, I really don’t know how much that has a part to play. Even though I’d like to think that for me my choice was entirely rational, I doubt that it was, you know, I really do.

How did it feel sort of being approached to take part in a trial at a time when it was kind of vulnerable?

Yes, it’s difficult, isn’t it? And it, and it’s one of those kind of difficult things when you’ve got someone in crisis yet you need really to get a signature off them ideally. And I could see that in the staff. I think part of my willingness to; to take part was that everyone was incredibly nice. And I mean the neonatal care we received was absolutely excellent, first rate. And I think that probably kind of helped us warm to being compliant and easy-going parents as, as far as all that happened. And I was also in the same hospital for my pregnancy, and again I had absolutely excellent care from the fetal medicine department. So we felt, not that we owed the hospital something. That was wrong. But, you know, that there was certainly a kind of bit of, well, you, we have been treated, you know, like royalty and they have kept a child alive which, you know, could have easily have died, and everyone has worked their hardest and absolutely done beyond their call of duty. So actually, do you know what, we can do this, because we can see that it’s something that really matters to them. Had I not had such positive experiences I might not have been. I think possibly, but I don’t, it’s difficult to say, isn’t it? But certainly the atmosphere and the approachability really by the consultants, so, you know, very senior doctors making themselves very, very approachable and explaining things very well certainly had a part in me saying, That’ll absolutely be fine. Of course we’re happy to help

So that was our second trial, which, which was fine. And I was very happy to take part in them. I mean obviously in, in terms of time it, it didn’t really impinge on us at all because we were in hospital anyway in a neonatal unit. So our child being given antibiotics, he would have been given antibiotics anyway. You know, it didn’t particularly affect things. The only thing it did affect was I suppose the two-year appointment, but that was on the back of a hospital appointment so it was made as easy for everybody. So it had a very low impact really upon us and the family. More interesting to read and, you know, from a healthcare perspective, and, and, and to see, you know, those kind of developments and how people are thinking and how that affects, you know, medicine really. So that was that trial.

You have no control over that. You know, as far as I was, I think it’s a computer isn’t it that does it. And so there you go; the decision is made for you. You just make the decision on whether or not you’re going to be happy with the outcome. So almost the outcome has to be irrelevant, because you’ve got to be able to sit with whatever the outcome is. And I think that’s what you need to focus on. How do I feel if it’s a weight-related dose or, you know, How, how do I fee And I think providing you’re okay with that, then it’s

How did it feel sort of being approached to take part in a trial at a time when it was kind of vulnerable?

Yes, it’s difficult, isn’t it? And it, and it’s one of those kind of difficult things when you’ve got someone in crisis yet you need really to get a signature off them ideally. And I could see that in the staff. I think part of my willingness to; to take part was that everyone was incredibly nice. And I mean the neonatal care we received was absolutely excellent, first rate. And I think that probably kind of helped us warm to being compliant and easy-going parents as, as far as all that happened. And I was also in the same hospital for my pregnancy, and again I had absolutely excellent care from the fetal medicine department. So we felt, not that we owed the hospital something. That was wrong. But, you know, that there was certainly a kind of bit of, well, you, we have been treated, you know, like royalty and they have kept a child alive which, you know, could have easily have died, and everyone has worked their hardest and absolutely done beyond their call of duty. So actually, do you know what, we can, we can do this, because we can see that it’s something that really matters to them. Had I not had such positive experiences I might not have been. I think possibly, but I don’t, it’s difficult to say, isn’t it? But certainly the atmosphere and the approachability really by the consultants, so, you know, very senior doctors making themselves very very approachable and explaining things very well certainly had a part in me saying, That’ll absolutely be fine. Of course we’re happy to help

Yes, no, that’s interesting. And I did think that. And that was flagged up for us by the research nurse, was that you’d have more clinic appointments, you know, and that could be, she didn’t, she said it in a nicer way and a bit more subtle way, but actually that could be of more benefit. And I remember my husband saying, Well, look, you know, they get to check your blood pressure more and whatever And you kind of think, Yes And then actually when you think about it you think some of those things could be done in your GP’s surgery actually, to be honest. You don’t need to go to a hospital and have a consultant to do all of these things. But does that mean we’re being better monitored? You know, it’s a very attractive suggestion. And so maybe you think, Yes, I’m going to go with that But then does that then indicate that the level of care if you don’t do it is substandard? You know it does, implies that if you think that, so that’s slightly tricky. And I’m sure that does play a part actually in thinking. Although I think that would be the wrong reason to do something, I have to say, for us. I think you have to be accepting that the baseline care that you’re given is adequate, in fact more than adequate. But, yes, I do remember, no, I do remember that coming up actually, yes.

When you made the decision, did, was there any thoughts about the, the benefits to your son maybe?

Yes, I mean of course it, it would be. it’s difficult isn’t it, because no matter how selfless you try to be, I mean if there’s benefits to our children then we grab it. So yes, although it’s a kind of much wider spread than that. But, yes you know, if there was some benefit or some, you know, hint of something that could be helpful, then of, then, then of course. So, yes, from a very selfish perspective, yes, yes, of course. Like most people I’d say.

After the first year we then agreed to continue to have extra bloods taken. And also they do this day assessment where your children have to fast and they measure your blood glucose levels, and this extra scan. And we agreed to all that, knowing that we were having more tests than was absolutely necessary, with an overview of, Well, actually it’s going to be of benefit medically in years to come, but there’s actually no benefit for us now because it’s just an extra set of bloods, it’s just an extra test. So we did, we, we’ve done that and we’ve actually decided to stop now. We, we’ve come to the end of that period and they asked if you want to carry on and we’ve said, No; the reason being that our oldest child is eight and he’s at an age where he doesn’t want to have blood taken, and actually now he doesn’t need to have his blood taken. I think it might just be once a year, if that, or something. You know, we’re really down to the minimum, minimum things with the whole, the whole thing. And actually he doesn’t want to. And so that’s fine and I have to respect that.

Yes, yes, yes. I mean they do talk in hospital talk and I don’t know if that’s just a symptom of how hospitals work or whether it’s a symptom more of the department we were in which seems to have, be a department of precision, and absolute precision. Which is fine. I do sometimes have the feeling that they don’t, they, they don’t tell you absolutely everything. And if you want to know something, then you have to ask a question. So for example with the growth hormone and with the trial, and I should have found the email. But I, I remember emailing the research nurse with about seven questions which she replied back in absolute clarity and precision and detail brilliantly, but that information I had to ask to get.

What sort of information?

Well, I just wanted to know really, you know, about dosage levels, you know. And what, well, you know, in, in America it’s different to Europe, what happens to those children after the first year? They all go on to a weight-related dose. And the picture, you know, when we were asking is, is pretty sketchy. It’s just that you want your child to be on a, a low dose as possible. What, you know, are there any dangers in having a higher, higher dose? And what are the benefits? And then just more generally, what are the benefits to the treatment? you know. A good web, we looked at a good website actually, we got directed towards. It didn’t talk about clinical trials but it talked about growth hormone and the benefits. So that was helpful. And I think the more positive we felt about the treatment and making that decision to do it and getting into that, Actually we are going to go ahead and do this. There are some positive things. This is really interesting, what I’ve just read, you know. You then become in a more positive framework for moving on to the next stage of accepting a clinical trial. So I think you have to be in the right place. Because to begin with like it did feel like, Gosh, this, this, yes, a big decision and maybe a step too far.

That’s the other thing I would say. With all the acronyms that are used in medicine, I can’t even remember now what the name of the trial is. And I’m sure it just rolls off the tongue. And I think that is a little bit off-putting sometimes. You know, I think parents need things in very simple [terms]. Yes, yes, no, I know, I know. But then when you read them sometimes they are kind of quite, feel sometimes a little bit cobbled together. [And you’ve got to remember all the words.] Yes, in, in between, which, shall I move on to my next point? [Yes.] Which was, I was asked if I wanted to be a parent representative for a trial, a neonatal trial. This would have been in 2004, yes. It was just simply I knew one of the neonatal consultants. He, and I’d been involved in setting up a, a group for parents and it was kind of on the back of that really. Would I… there was another parent asked as well, Be a parent representative on a clinical trial that, that was happening at the moment? I said, Yes. Now I didn’t actually go to any of the meetings because I had a brand new baby, some were in [area], some were in [area], and actually my friend at that stage was quite happy to go. So, but I read most of the stuff that was sent. And what they were interested in was really as, as a parent, how it, what it feels like, and actually what they can do as staff to ease any anxieties which, which comes about. Now the trial was actually stopped as it happened, so it was actually quite a short period of time that [um] kind of, yes, reading all these emails and things. And I think kind of one of the things that was flagged up then is the confusion of names for parents. You know, it, it’s,it’s meaningless. It’s not meaningless if you’re a medic but, you know, if you’re not it just adds to confusion.

One of the big things you talked about was mortality and how you convey, you know, at the end of the day a parent wants to know whether their baby is going to live or die, and, you know, and how you convey and how you use those terms. So, yes, and it was to do with insulin and neonates with a low birth weight in different hospitals all around. So, but the doctors, as far as I know, that were heading the trial were all based in [area].

So this is for another trial?

Yes, this is for another trial, which we weren’t part of it. It was just simply whether we’d be [um] a parent representative. Which I think is a really good idea. The downside of it is the meetings are quite long. And I think in this case it was a group of absolutely lovely consultants meeting, who would make you feel incredibly welcome and really value your input. You do it for free, and it has to come at the right period of time when you feel you can do that. But I think it, in essence, it’s a really, really, really good idea because I think it’s very easy to lose sight, you know. You have all your tables and all your statistics and everything, and that’s how it needs to be of course. But actually there is a parent with a baby at the end of the day, and it’s a personal cost to them, you know. And nobody wants to be a, seemed that they are a set of figures or a box that you can tick. You know, they’re a person. And I think the point we made was really, it was just trying to encompass parents’ needs. Having said that, the feeling I got from reading through things and certainly talking to my friend who went to more or less every meeting was that people were incredibly thankful for parents who took part and actually had the utmost respect, respect for them. So it wasn’t a thing you did, you know, and it was brushed aside. They were absolutely, you know, grateful and really respected that.

And I do remember actually being given at one clinic appointment loads of information. But it was almost like a bit too much. And I do think when you have piles of things, then to flick through in a hospital, actually I need to sit down, I need to do that at home quite quietly and calmly with a pen, I need to underline. Do you know what I mean? That’s how I work. I can’t do things as I’m walking down a corridor or thinking of something else, I really can’t, and so that, although the information was there and it was all about numbers and everything, I, for me that wasn’t the best way. I could have done with that information being given before, you know, like a month in the post before. And then maybe a follow-up phone call to say, Have you read it? Do you have any questions Or an e-mail actually. Yes, I think so. I think time is, is a key thing. You need time to think about these things.

The second trial that we were signed up to, I can’t remember the name of it. And that was to look at preterm babies under a kilo, so we, you know, fitted that perfectly, and to look at the use of antibiotics to reduce sepsis. So our understanding of it was that sepsis is a kind of a, really a primary cause for neonatal mortality and it’s a, a big concern for any neonate, and we want to do what we can to minimise that risk as parents. So it was a randomised trial where you were either picked to have the antibiotic or you weren’t. it’s used in paediatric medicine and has been extremely successful, so it was now looking at whether it could be applicable and transferable to a neonatal unit. Everyone was really positive about this and the vibes we got was that it was a really important trial and it was great to be part of. And it would be great actually if we got given the antibiotic because we had a very small low birth weight baby who, as everyone led us to believe, would benefit from this. So we were quite happy to do that, because actually from all the reading and all the background material I’d done, you know, sepsis seemed to be a huge, huge risk, especially to us. So actually if we could do anything to minimise that risk then, you know, that was great. So we signed up for this, and we were given the antibiotic. Now we were approached by a consultant and also a registrar as well, who explained very, very well what we, what we had to do. So I don’t feel that we didn’t get given enough information. I felt that there, there was a lot of information there. And our child was given the antibiotic and everyone was very pleased about that. I didn’t really think too, too much about that. Now we knew as part of that trial they were also going to follow up development at two years and then again at five years. Looking at dosage, we were given good information and the vibes we got that, was that it was a really, was really good that our child had, had been picked to, to have the antibiotic. And I was aware in the neonatal unit of other parents being invited to take part in, in the trials as well and also aware when people weren’t picked to, to have the antibiotic as well.

There was a follow-up at two years and then a follow-up at five years to look at development. So we had a two-year follow-up in [hospital name] actually. And then we got the results of those all printed out and all written up and posted to us. We had copies to give to our GP. And then the trial itself, they were brilliant at communicating actually. So you get, I think kind of two, yes, probably every six months a newsletter comes out, you know, about the number of people who’ve been recruited, what’s going on, what they thinks’ happening. They even send us Christmas cards I do believe. I think they might have stopped that now. But it, it was, the communication, you know, was really very good. And actually what they found with the antibiotics is that it doesn’t make any difference whatsoever. So that antibiotic is not going to be used in neonatal medicine. So that was quite surprising actually, because that wasn’t what we’d been led to believe. So that’s quite an interesting turn on, you know, why you need clinical trials actually to, even though everyone had a good feeling and it had been very successful in paediatric medicine, for, for neonates that wasn’t applicable. So that was quite interesting. So we had the antibiotics for nothing. But never mind. I’ll put that down to, that’s just the way it goes. That was the purpose of it.

Because our child has never caught up in height and weight, we were suitable should we want to go ahead with growth hormone treatment, which we opted to. And at that stage, once we said yes, we were then asked whether we’d take part in a clinical trial. Now that, you know, that was a slightly harder decision in many respects to make because it has been costly in terms of time really, which is why we’ve decided not to go any further with it. So our child has growth hormone treatment, treatment which is inject, he’s injected with growth hormone daily to, to, to make him grow at a normal rate. And in the first year there’s some uncertainty as to the best dosage, and models are different in America as they are from Europe. So we were part of a trial to see which dose is the best really. Now as it happens we were given the lowest dose, which is great, great for us. And so far it looks like children do very well in their first year on the lowest dose actually and don’t need to be put on a higher dose. So we went into that with a little bit of anticipation because obviously I don’t know what dose before, we, you know, what we were going to be given and I don’t, you know, like most parents you don’t want to inject your child with some synthetic growth hormone if, if, if you don’t need to.

So that was a little bit more, I can’t quite see the benefit for u but I can see the bigger picture in that, you know, ten years down the line this needs to be more finely tuned as a treatment. And although growth hormone, as far as I understand, has been used in the UK for quite a while, it still, well, certainly it still feels a little bit embryonic at, at, at times. And, you know, for example the best dose for a 4-year-old isn’t standardised. So that was a bit harder. And we went into it thinking, Well, actually if we’ve signed up to thi which we have, because we signed up to injecting him with growth hormone till he’s 18, it’s a big commitment
And that was a hard decision to make because the only benefit is that our child is going to grow and not be extremely small in size and height. You know, there’s nothing medically wrong with leaving him small but, you know, we have decided to do it re-, really from a social point of view. So then to take part in a trial whereby it felt, you know, slightly like these dosage levels have still, you know, still need tweaking and it seems a little bit uncertain was much more, you have to think of a bigger picture as I say. So ten years down the line it will be really nice for children going through this to know, I don’t know, the medium level of, you know, that’s where you need to be or, you know, and, and for people to have a much bigger picture. And my feeling is, and it might be wrong, there are not that many children, you know, go, you, through the process we have. Most do catch up. So these small for, you know, small for, small for gestational age children, there aren’t that many of them about, although I might be wrong. So actually it’s really important that they try and catch us and get us to be part of it.

The second trial that we were signed up to, I can’t remember the name of it. And that was to look at preterm babies under a kilo, so we, you know, fitted that perfectly, and to look at the use of antibiotics to reduce sepsis. So our understanding of it was that sepsis is a kind of a, really a primary cause for neonatal mortality and it’s a, a big concern for any neonate, and we want to do what we can to minimise that risk as parents. So it was a randomised trial where you were either picked to have the antibiotic or you weren’t. it’s used in paediatric medicine and has been extremely successful, so it was now looking at whether it could be applicable and transferable to a neonatal unit. Everyone was really positive about this and the vibes we got was that it was a really important trial and it was great to be part of. And it would be great actually if we got given the antibiotic because we had a very small low birth weight baby who, as everyone led us to believe, would benefit from this. So we were quite happy to do that, because actually from all the reading and all the background material I’d done, you know, sepsis seemed to be a huge, huge risk, especially to us. So actually if we could do anything to minimise that risk then, you know, that was great. So we signed up for this, and we were given the antibiotic. Now we were approached by a consultant and also a registrar as well, who explained very, very well what we, what we had to do. So I don’t feel that we didn’t get given enough information. I felt that there, there, there was a lot of information there. And our child was given the antibiotic and everyone was very pleased about that. I didn’t really think too, too much about that. Now we knew as part of that trial they were also going to follow up development at two years and then again at five years. Looking at dosage, we were given good information and the vibes we got that, was that it was a really, was really good that our child had, had been picked to, to have the antibiotic. And I was aware in the neonatal unit of other parents being invited to take part in, in the trials as well and also aware when people weren’t picked to, to have the antibiotic as well.

There was a follow-up at two years and then a follow-up at five years to look at development. So we had a two-year follow-up in [hospital name] actually. And then we got the results of those all printed out and all written up and posted to us. We had copies to give to our GP. And then the trial itself, they were brilliant at communicating actually. So you get, I think kind of two, yes, probably every six months a newsletter comes out, you know, about the number of people who’ve been recruited, what’s going on, what they thinks’ happening. They even send us Christmas cards I do believe. I think they might have stopped that now. But it was, the communication, you know, know, was really very good. And actually what they found with the antibiotics is that it doesn’t make any difference whatsoever. So that antibiotic is not going to be used in neonatal medicine. So that was quite surprising actually, because that wasn’t what we’d been led to believe. So that’s quite an interesting turn on, you know, why you need clinical trials actually to, even though everyone had a good feeling and it had been very successful in paediatric medicine, for, for neonates that wasn’t applicable. So that was quite interesting. So we had the antibiotics for nothing. But never mind. I’ll put that down to, that’s just the way it goes. That was the purpose of it.