Laura - Interview 31

Age at interview: 32

Brief Outline: Laura's responded to a recruitment poster while waiting for a routine scan at her local hospital when pregnant. Researchers were looking for volunteer mums to take part in a randomised trial on the prevention of eczema.

Background: Laura is 32 years of age, married and describes herself as White British and lives with her husband and two children ages four months and four years. Laura works full time for local government and is currently on maternity leave.

More about me...

 Laura, aged 32 years, is married and describes herself as White British. She lives with her husband and two children ages four months and four years. Laura is currently on maternity leave from a full time position in local government.

 

Laura’s eldest daughter has quite bad eczema that requires treatment several times a day. Laura saw a recruitment poster in the hospital when attending an appointment for a routine scan when pregnant with her second daughter. Because the study was on the prevention of eczema she decided to find out more about it. She contacted the researchers by email and they responded and asked Laura some questions, such as family history of eczema, to determine if she was eligible to take part, which she was.

 

A few weeks after Laura’s second daughter was born, the researchers came to visit Laura at her home to give more information, written and verbal. Laura says there was plenty of information and everything was clearly explained and there were numbers to ring if she had any questions.

 

Parents were randomly allocated to either of the trial groups. Laura was in the group that received one of three emollient creams. Laura was pleased that she could choose which of the three creams she preferred to use; she chose Sunflower oil. The others included a light cream and a more Vaseline type of emollient. Laura has to apply the oil daily. However, she says that all parents in the trial received a £15 voucher to buy baby products, so even the parents allocated to the comparison group could buy an emollient cream or wash of their choice.

 

Laura is still in the study which continues until her daughter is six months old.

 

Laura thought it was all very well organised and the research team have been very helpful and supportive. Although the nurses and Laura know which cream she chose, the researchers do not know. Sometimes this is called a single blind study.

 

Laura would consider other research studies in the future as long as they were minimal risk to her children.

 

Laura will continue with the skin care advice for her daughter she received during the trial, and...

 I don’t, no, I don’t think they’re going, there’s no follow-up, they won’t keep checking on her. Six months is the end of it. But I will just be interested to know the outcome in the fullness of time, see what the results were. Obviously very keen at the six-months check-up to get the results of the, genetic test, take full advantage of the appointment with the consultant where he, where they will check Beth over really, really thoroughly, and take any advice that the skincare consultant gives. Particularly if she is showing signs of, of eczema, then at least I’ll feel like I’ll have a head start.

 

Are you hoping that the results of the genetic test will be a negative result?

 

I am. And but if they aren’t, then it makes the taking part in the study all the more important in terms of whether oiling will have made a difference.

 

And if they said if it’s a positive result, have they, kind of did they say what would happen then? Or are you just left?

 

Well then it’s GP’s care to deal with it. But of course if she’s showing moderate signs of eczema, then I would probably keep going with the oil and hope that it would, would at least lessen it. We’ll have to see. We’ll cross that bridge when we get there.

 

It was explained that the risk of side effects were very low.

 There was something in the literature and I, and I do believe they made me aware of, of the, any, any potential risk factor. But the risks are extremely low with this.

 

Did they say what they were? Can you remember?

 

Well, there’s, they, they tried as, as far as they can to rule out the risk of allergy, because these things are, are, are, have been chosen because they, they shouldn’t result in, in allergy. So I clearly remember them talking through that. It is I believe that the risk is that by interfering with the, the skin barrier they don’t know whether it could actually make things worse rather than better. I suppose if the baby’s barrier, skin barrier doesn’t, isn’t allowed to progress naturally. But I believe that that risk is low and it was certainly a risk I was prepared to take.

 

Laura will ask the researchers if the results will be posted on a website. She would also like to...

 I don’t think so. But I, obviously being a new mum and not getting a lot of sleep, there might be some things I’ve forgotten. But I don’t think, I don’t think, because they, it takes a little while, doesn’t it? To collate that sort of information. And of course other people won’t be, there will have been babies starting after Beth. So I suspect it’ll take quite a few months to, to get that information in.

 

Is it something you would like to know?

 

I’d definitely like to know, to know the results, yes.

 

I’ll ask at the, when I, when we have the final appointment. It’s one of the things that I will ask and see whether they might put something on a website or something that we can just see. Because they’ll no doubt publish, publish the results somewhere, if, and so if they don’t provide them to me I’ll want to know where I can find them.

 

I’m, well, I’m actually keen to know where they’re going to go with the study next. So the, the, the lady who came to speak to us after three months did hint that they were hoping to extend the study and increase the scope of it. So I would just want to know, to know more about that and to see whether they, they had any preliminary results, I suppose. And like I say, to make sure that I could get my hands on the results wherever possible in, in the fullness of time and see, see how it had gone. Because even if the genetic test comes back and Beth wasn’t likely to get eczema, I will, or if she does get eczema at the end of it, just taking part in the study at least we’ve had a go at helping ourselves and potentially we’ve helped to get more information for other, other families with children with eczema as well. So all, in all that’s a very good thing, I think.

 

Laura would have liked to talk to other parents whose babies were taking part in the trial, for...

 I don’t know if it’s already done in certain studies, but I suppose if it was a, a potentially harder study or, or maybe in the early days of this study even, I might have benefited from being able to chat with other people who were taking part, maybe on an Internet-based, you know, a web-based thing. So I could have, you know, said, “We, our baby isn’t really enjoying not having any clothes on while we oil her to begin with. Is anybody else experiencing this? Have you got through it? Is it, is it getting better?” And just, potentially just help each other out a bit on the, on the tough times. I suspect in other studies that that might already happen. And it might be very very helpful if it’s a, potentially a less, less pleasant thing that, you know, something with more side effects or something where you’re constantly worrying about whether you’re doing the right thing. Then, then a little bit of support from, from other people in the trial might be useful. Maybe that, maybe part of that is because, because it has to be, maybe it makes it more scientific if you’re not talking to other people. But, but potentially it, depending on the circumstances of the trial, there might be a little bit of that. Because I could always have, have rung the, the, the people involved in the trial and said, “Oh, I’m having this trouble.” And I’m absolutely sure they would have given me lots of moral support. But it was just a thought.

A member of the research team first contacted Laura by telephone to see if she and her baby would...

 So when we were pregnant with my second baby, we went to a routine scan one day and saw a poster in, in the waiting room and it, it was talking about prevention of eczema in babies and young children and it was called the BEEP study. And we thought, “Well, okay, if there’s anything that we can do to prevent our second child having eczema then let’s get involved. And at least we could get some information.” So we e-mailed them on the, the contact address. And they got back to us quite quickly and talked us through whether we were eligible, that we had a history of eczema in the family and, and that sort of thing, and that the baby hadn’t been born yet and all of those things, and said that they would, we were eligible for the study, they’d contact us. They’d be notified by the hospital when the baby was born, they’d contact us, make an appointment and come and see us.

 

No, I didn’t see them. They, we did most of it over the phone. And then in the later stages of my pregnancy one of the ladies came round to, to see me here and to talk me through all of the paperwork and exactly what would happen, and gave me forms to sign and, yes, say, to say that I, to say that I was interested and was happy to take part and I was going to abide by what they said.

 

Was it all verbal information or did you have some written things as well?

 

There was some written, written information as well.

 

Laura's baby was also eligible to have a genetic test. Laura found it helpful to have written...

 And the other really good thing about it is that they’ve allowed us to do a genetic test, where they just took some skin cells from the inside of her mouth. And it was just a swab, well, we actually did it ourselves, this, in the end. And you get a sort of like a cotton bud swab thing and you wipe it around the inside of the baby’s mouth for a certain amount of time. And then you pop it back in the tube, send it off, and they tell you whether genetically she is likely to get eczema. So that’s also handy. And it’s been a very, very positive experience.

I think they explained everything extremely well. I probably asked, asked a few questions as we went along, just, just so that I was absolutely 100 per cent sure of, of what they meant. And, and I know I asked a few questions about the genetic testing. Because with that one obviously then, then your child’s genetic material is going to be out there, and, and so I was, I was keen to make sure that that wasn’t going to go any further. It was just [baby] that that was going to be used for the study only and couldn’t be identified. So it, it would never have her name on it, for example. Nobody would be able to tie it up to her apart from the people running the study. So it, I felt reassured by that that it was going to be safe.

 

I think that was fine because there was a, a lot of information. There was written information so that you could look at it in detail and, and really understand what was going on. And then there was also, they talked us through it as well. And that, that’s a comfort because then if you then realised afterwards that there was something that you’d missed, you’d got the written information to refer to, but also you could always pick up the phone and ask them or email them depending on, and like, and they have always been very nice and very patient.

 

Laura's daughter took part in randomised trial on the prevention of eczema in babies. Although...

 They’d be notified by the hospital when the baby was born, they’d contact us, make an appointment and come and see us. At which point we would be put randomly either into a control, control group where we wouldn’t be given any creams to apply or the group that were going to be given creams and if that was going to be the case then we would be given an option of three different types of emollients. So there was sort of a thick Vaseliney type cream, one that was more like the Diprobase that we use for our elder, elder child that’s a, a lighter cream, and then sunflower oil. And all of these had been they had been chosen because they shouldn’t create an allergic reaction and they shouldn’t in themselves be able to create a problem with eczema. And the idea being that potentially if you use one of these regularly at least every day and after bathing that you might be able to just help the skin’s barrier a little bit and it might prevent the onset of eczema. However, there is of course a very slight risk that if you are doing that and you are creating an artificial barrier, it’s not allowing your baby’s own skin barrier to develop in its own way.

 

So it seemed to us to be minimal risk and we thought, “Okay, well, we’ll take part in the study.” You got a, a Boots voucher for £15, which was quite nice, whether you took, whether you were in the control group who were not applying the provided emollients or whether, whether you were, whether you were using them. And this voucher was so that you could go to Boots and get soap-free bath things and any creams that you wanted, I suppose, if you were in the control group. And we thought, “Well, there’s nothing to lose here. There’s, and there’s potentially everything to gain.” So we’ve been taking part in that study now. We chose the sunflower oil because we thought that might be useful for baby massage as well. So it was a nice thing to do, spend a bit of time doing and make it into a bit of a feature, [that’s our baby] make it into, make it into a feature rather than an ordeal. And once we got into the hang of it and we got a bit of a routine going, and we lay out the towels and we oil her and she laughs and rolls around and it’s quite pleasant really.

 

The people that are involved have, have always been very nice, explained things extremely clearly. They’re always on the end of the phone if we’ve got a question and, and it’s been a very pleasant experience. We’ve not finished yet. We don’t finish until Beth is six months old. And we have to keep applying the emollient every day until then, whereupon she will be seen by a consultant, I believe, and they will check for any signs of eczema. And this, this person won’t know whether she’s been in the control group or the group who have been applying the emollient. So they will be able to say without prejudice what, whether they think that she, she has developed any eczema or that is, is likely to or there are any signs at all. 

 

Because of her elder daughter's experience of eczema, Laura would have been disappointed if her...

 And I think as well if I’d been in the control group and not applying the emollient every day, I think that I would have been a little bit disappointed then as well. Because that would just have simply repeated what we’d done with our eldest child in a, in many respects. And I think that would have been a, a bit of a shame. So I feel at least we’ve had a go and done everything we possibly could.

 

I did, yes. It, it was a simple, it was done by computer. And they, they came to see me after the baby had been born, within the first couple of weeks, because obviously you, you’ve to start as soon as possible but not, not in a, not in an, a way that imposes on you. So they, they didn’t come within the first week, for example, because you, it takes a bit of time to settle with a baby. But as soon as it’s reasonable and within the first three weeks I think it was, had to be, they came round to see us, and from here made a phone call to see whether we would be in the control group or not. And it apparently came back randomly selected that we would be taking part in the study.

 

And did they say at that point, obviously you’re using the cream, so you know which cream, so you know which cream?

 

Well, they, at that point, that’s when they, they say, “Well, which of these creams?” And they allowed me to test them, and my husband was here as well, so that was quite nice. So we could make the decision together. So we tested them on our, our skins to see whether we, how we felt about them and, and, and made our choice. And we use the sunflower oil.

 

So there, how many creams were there?

 

There were three. So there was a Vaseliney type texture one, and a lighter cream, and then the sunflower oil.

 

An oil? So there were, so there were creams and an oil?

 

Yes. Because there might be a difference, I suppose, within the study with which emollient that you use as well as if you use one at all.

 

I was just wondering how they worked that with the, with going in, with the three groups.

 

I’m not sure. I don’t know. I, I did say, the, the Vaseliney one, the very thick one didn’t, it just was so gloopy and unpleasant in my opinion, and I did say, “How many people have chosen this?” and she said, “Not many.” So I don’t know, I don’t know how they do that. But I suppose they’ll be able to get a more random cross-section with that if, if the study continues. And if this is just to get some initial results then I, then that makes sense.

 

And you say, and the, obviously the nurses will know which one you were on. You were there, were, they were, when you picked it? But the, who’s looking at it doesn’t know?

 

No, the consultant has no idea whether we’ve used anything or, of what we have used, which one.

 

Yes, it was. That, and I think that’s important. In a study where you, where it’s, you’re going to put something on your child, I think it’s important that you’re comfortable with, with what it is.