National Children’s Study to Assess Environment and Genetics
In a press release yesterday, the National Institutes of Health announced that the first Vanguard Center of the National Children’s Study had begun recruiting volunteers. Yesterday, we interviewed Dr. Phil Landrigan, who will lead the Queens, New York, site. In yesterday’s post, Landmark National Children’s Study Launches in US, Dr. Landrigan explained the purpose of the study and drew parallels with the Framingham Stroke Study.
Today, we bring you Dr. Jeff Murray, neonatologist and medical geneticist. Dr. Murray will be principal investigator for the Polk County, Iowa, research site, which is expected to begin recruiting participants in 2011. He provides us with insights into how the study will work on a local level. In future posts, we’ll introduce you to other researchers who are involved in the National Children’s Study and announce findings as they are released.
Blue Planet Green Living (BPGL) spoke with Dr. Murray from his office at the University of Iowa Hospitals and Clinics in Iowa City. We asked him to tell us about the study from his perspective. — Julia Wasson, Publisher
MURRAY: My first involvement with the study was that I was asked to serve on the committee for how the study would be implemented. A previous group of scientists and physicians based at the National Institutes of Health and the Mental Health Institute had come up with an initial plan on how to carry out the study. Then they brought in scientific expertise to help with the research design, and I was a part of that process.
As a pediatrician, I saw this as holding out the promise for providing us with much better insights into both the causes and treatment of diseases of infancy and childhood. I also saw that it had a huge amount of power to address really important questions and, as a result of that, I was certainly very enthusiastic about the study.
One of the things the National Children’s Study is going to do will be to investigate some of those common disorders of childhood. Hopefully, that will give insights in the future into causes and outcomes. We hope to identify and enroll 100,000 infants prenatally, and then to follow them from their prenatal time through birth, and then on up until early adulthood.
The goal is to collect information on their environmental exposures as well as their genetic background, and to use that information to identify the causes of disease. While 100,000 sounds like a very big number, and it is, it will be best suited for identifying the causes and complications of common diseases of childhood, things like asthma and diabetes and autism and prematurity — things that will affect thousands of the children in the study.
BPGL: How many children will be in your portion of the research study?
MURRAY: There will be 1,000 children in Iowa. There will be 105 sites nationally, in 105 counties. There’s only one county in Iowa, which is Polk County.
BPGL: Will new babies and mothers be enrolled year after year, or will you enroll all 1,000 in the first year?
MURRAY: All the babies aren’t enrolled in one year. They’re predicted right now to be enrolled at a rate of about 250 a year in a given county. So in Polk County, we would be enrolling over probably four or five years.
Some counties are large enough that we wouldn’t be able to enroll every single pregnancy that occurs in the county. [In that case], before the study begins to enroll people formally, the team will go around to individual communities and literally knock on the door of every single person in that geographic area. In Polk County, that’s predicted to be about 15,000 households. And from those 15,000 households, they’ll ask people if they’d be willing to enroll in the study.
BPGL: How are you going to knock on 15,000 doors?
MURRAY: It’s not a volunteer effort. It’s funded by the NIH, so by the time the door knocking comes around, there’ll be in the vicinity of about 20 people doing that.
One thing I would like to emphasize is that the university and myself act as the principal investigators, but that the bulk of the work is going to take place in Polk County under the direction of Dr. Rizwan Shah, a pediatrician at the Iowa Hospital Systems. It’s probably important to note that there’s been a real coming together of the different hospital systems in making this program possible. I am honored to be a part of a community that was willing to put aside what are sometimes competitive interests to recognize that this is important for children. We had to have a buy-in from all the hospitals in Polk County to make this work. They were all very eager and very enthusiastic in their support of the project.
BPGL: Will you be doing any awareness activities so that people are anticipating that someone will knock on their doors?
MURRAY: There will be a big community engagement effort before the study starts, where there will be posters and fliers and news announcements and radio and TV shows talking about the study to make the community aware of it. We hope that it will have a very high profile in the community before people go out and begin to knock on doors. And we’re going to work through individual communities and community organizers so just a random person won’t show up. We’ll have previously gone to the community organizations, the churches and the political organizations and the health organizations and so on, and try to work with them about the best way to contact people as well.
Volunteers have to sign a consent document in order to be able to participate. They’ll be followed until they become pregnant, and through pregnancy and beyond. We expect that by knocking on the doors of about 15,000 homes, we will end up getting somewhere in the vicinity of 250 pregnancies a year. Not every woman, of course, will want to be in the study, so we have to knock on more doors than people are likely to present with pregnancies.
BPGL: So you’re identifying moms long before they decide to get pregnant?
MURRAY: The idea is to enroll them pre-pregnancy. The perfect study subject is someone who, before she even becomes pregnant, has been enrolled in the study and has been followed along. But we also recognize that most pregnancies are unplanned, and so people can be enrolled at the time of birth.
BPGL: In Dr. Landrigan’s interview, he talked about the kinds of sampling of the mothers’ and children’s environment that will be done over the life of the study. What is the genetic element of the testing?
MURRAY: At each of the visits, the team will do blood samples that allow them to do both genetic studies and also to measure things in the blood, like chemical exposures.
We’ll be looking for variations in genes that contribute to the onset of disease. All of us have thousands and thousands of individual genes, but many of us have small variations in those genes that express the work that the gene does in slightly different ways. We’ll be looking to see whether that genetic variation in the gene, things like blood groups — for example, you can be A, B, or O blood group, or Rh positive or negative — to see whether those differences affect the onset, or the likelihood of you getting a disease. And we will have, probably, millions of genetic variants studied in each individual child.
BPGL: As you are studying these children, will the parents get any advice as far as diet and so on? Or are you just observers, who are not going to influence anything?
MURRAY: The study is not meant to provide advice. But, if parents ask, we’ll provide them with resources that are available in the community or through their own physicians. It’s not meant to replace typical pediatric care, even though they will have typical assessments done, things like growth and development assessed. It’s not meant to replace what their pediatricians would normally do anyway, but if we identify relevant abnormalities in a child, for example, we would refer them back to a primary care provider to enable the child or adult to be taken care of. We’re certainly not going to hide things from anybody if we find them.
BPGL: How soon do you expect to have results? Will we have to wait 21 years to learn the research findings?
MURRAY: The study itself will be putting out materials as time goes on about the results, so that people will be able to benefit from what we learn. We should begin to have findings in just a few years.
BPGL: Will the people be incentivized for their participation?
MURRAY: They’re being reimbursed for the cost of the time that they would put into the study. Depending on how much time is involved in doing an interview or having a sample taken, or so on, they’re reimbursed for that.
BPGL: What if they move, are they then eligible to go to another site in another state?
MURRAY: The hope is that they will continue to be enrolled in the study, and if they move to a place where there is also a study center, then they can continue to be followed through that study center. And there are also going to be teams who will go out and try to identify people who have moved some distance away. The retention in the study is, of course, a key factor to it being successful.
BPGL: Considering that Polk County is located in Iowa, where farmers raise a huge percentage of genetically modified crops, do you expect you’ll be able to find evidence of the presence of genetically modified organisms (GMOs) in babies?
MURRAY: The research is designed to try to address questions like that. We’ll be taking nutritional surveys from the mothers, so we’ll know what their diets are, what their food sources are, and insofar as those food sources can be traced back to genetic modifications, we will have that data. We will be collecting blood samples and urine samples from the mothers and the babies, so if elements of those foods would be present, they would be potentially detectable. I would also say that that sort of detection and the role of those remains controversial. But I don’t think that means it shouldn’t be studied, just that we should do the best job we can in studying it and determining whether those factors are both present and influencing the outcomes.
BPGL: As a neonatologist and a medical geneticist, how does your background color your interest in the study?
MURRAY: I have a particular interest in pre-term labor, and I’m very interested in some of the nutritional factors that predispose to babies being born prematurely — things related either to the mother’s health background or her diet. We’re interested in the role that some common dietary elements, things like Omega 3 fatty acids and cholesterol and others, play in preterm labor. I’m especially interested in learning about the outcomes of that, in part because, although the genetics is very exciting and interesting, it’s difficult and challenging to be able to manipulate genetics in the short term. There are lots of challenges associated with that. [On the other hand], the environment is something that we can sometimes be more effective at changing in the short term to effect preventions or cures. And so, if we could learn, either through the genetics or through the environmental studies directly, about nutritional causes or risks for preterm labor, that might be something we could offer to women as an effective preventative mechanism.
BPGL: Are you willing to speculate what you might find?
MURRAY: I’m willing to speculate in a very general sense. I think we’ll learn that both genes and environment play a role in childhood diseases. We’ll learn that some children are at much higher risk based on their genetic background than other children for acquiring certain diseases. And we’ll learn that the role of environment, nutrition, exposures to environmental toxins will probably be very important.
As a scientist, we want to keep our minds open and be willing to entertain all the possibilities and let the data tell us what’s happening, rather than try to make predictions which can then sometimes force things down a path.
We don’t know what is going to happen in the next 25 years. What are the dietary changes, the lifestyle changes, what are the community changes? The goal of this study is, instead of having to wait 25 years and look back to figure out what happened, we’ll be capturing that data in real time. And as soon as there’s sufficient data, we’ll be able to identify new causal mechanisms and be able to address them more quickly.
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