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.

 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.

 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. 

 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.

 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.

 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. 

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

 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.

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.

 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. 

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

 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.

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

 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 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 feel…?” And I think providing you’re okay with that, then it’s….

 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.

 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. 

 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?

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 now” you know. And that’s very much how it seems to work. 

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.

 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.

 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.

 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. 

 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’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 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, 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 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.

 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.

 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. 

 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].

 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. 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.