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National Children's Study will boost research here and nationally

This article first appeared in the St. Louis Beacon, Dec. 21, 2008 - Two-year old Maya Rideout is doing very nicely, thank you. But she wasn’t always a healthy child.

Because her mom, Reggi, developed severe eclampsia during pregnancy, Maya was born three-months early and weighed in at less than 2 pounds. She was on oxygen for 15 weeks after birth. Her muscles were weak, and she developed problems using her left hand, both from being in an incubator for so long. Thanks to physical and occupational therapy, she is fine now, but she has certainly seen her share of doctors and therapists.

Reggi Rideout says “We have been devouring all sorts of information about causes of eclampsia. We wonder every day how my pre-eclampsia affected her development in the womb, and what effect prematurity will have on her life.”

The National Children’s Study plans to find definitive answers to the Rideouts’ questions. This gigantic health initiative will examine the effects of both genetics and the environment on the health of 100,000 children nationwide. These children, who will be followed in some cases from before conception to their 21st birthday, will be chosen to the study will have representation for different socioeconomic backgrounds, ethnicities, race, and community structure. Medical histories of parents and child, biological samples, and environmental data will be regularly collected, and subjected to analysis.

Saint Louis University leads locally

Terry Leet, Ph.D., of the Saint Louis University School of Public Health, has received contracts totaling $53.1 million in the past two years to collect data from 4,000 children in four local areas: St. Louis City and Jefferson County in Missouri, and Macoupin County and Johnson-Union-Williamson counties in Illinois. Washington University, Southern Illinois University (three campuses) and St. Louis Battelle Memorial Institute will be partners in the project.

St. Louis is one of 36 study centers across the country. One hundred and five preselected counties will be represented, each enrolling 250 babies for four consecutive years. The study aims to gather enormous amounts of data on each child, including medical histories of both parents and child for 21 years. The investigators will assess the child’s home environment, looking at such factors as safety, population density, access to parks and other outdoor recreations. They will have data on the family structure, and how it changes over the years.

To answer environmental questions, such as exposure to lead or pesticides, they will collect specimens of water, air, dust and even soil samples. Parents and newborns will give biological specimens such as blood, urine and saliva. All specimens will be sent to a national repository and stored for further analysis.

The Planning-administrative team for the Gateway study area are Lisa John, Battelle Memorial Institute; Terry Leet, Saint Louis University; Kevin Stillman, Saint Louis University; Amanda Harrod, Saint Louis University; Louise Flick, Southern Illinois University, Edwardsville; Karen Tucker, Battelle Memorial Institute;: Allison King, Washington University and Vetta Sanders-Thompson, Washington University

A boost to research – and the local economy

Those who study children’s health have lots of questions, but very few answers. As a simple case, take the rise in childhood obesity. Obviously, these children are taking in more calories than they need. But why? Do the obese children spend more of their days watching TV or playing computer games than other children? Do they eat more junk food or just more food? Does daily gym and recess in school — or its absence — have an effect on obesity?

The study will concentrate on several serious childhood problems ranging from premature birth and birth defects to onset of puberty and contraction of sexually transmitted diseases in older children. Asthma, autism, learning disabilities, diabetes and mental retardation are only some of the problems the study is expected to address.

This study is estimated to cost $2.7 billion over 25 years. More than $50 million will be injected into the St. Louis economy in the next five years, as interviewers, visiting nurses and other staff collect and organize the data. In addition, analysis and application of the collected data should generate an enormous savings in terms of our national health care system. Every year, diabetes costs the country $132 billion, autism $43 billion, and asthma $11 billion. If the findings from these studies lead to only a 1 percent annual reduction in these three diseases, the savings would amount to $1.86 billion in a single year.

Congress initiated the National Children’s Study in 2000. From that time until the present, scientists and health professionals, along with representatives from the federal agencies sponsoring the study — the National Institute for Child Health and Human Development, the Environmental Protection Agency, the Centers for Disease Control, and the National Institute for Environmental Health Sciences — have worked on hypotheses that will be used in devising questionnaires, testing for specific environmental factors and using genetic data from the Human Genome Project.

One hundred thousand children seems like a huge number, but it will be barely enough to study diseases in the population at large. To understand why the size of the survey is necessary, a bit of calculation is called for. Diagnosis of autism may be increasing 20 percent every year, but thankfully, the percentage of autistic children is about 0.6 percent, or a possible 833 children of the total 100,000 children surveyed. Eight hundred could give a meaningful data set when comparing links between autism and environmental factors. Smaller sample sizes create greater opportunities for sampling errors.

How the study will work

The bi-state area surveyors will begin recruiting families in 2010 (St. Louis City and Macoupin County), and in 2011 (Jefferson and Johnson-Union-Williamson counties.) They are considered the first and second “wave” of the project. Seven “vanguard” centers will conduct the pilot study, beginning in 2009, and their experience will be used to refine the subsequent three waves of families that will be recruited for the entire study.

The first problem is how to choose 100,000 out of the more than 16 million births expected nationally in four years. Those chosen should be diverse geographically, racially, socioeconomically, religiously, and categorized as urban, rural, or suburban. Almost all states will have at least one of the 105 counties previously selected, so geographical distribution is guaranteed.

The trick is then to choose geographic segments within the participating counties in which to recruit participants by door-to-door canvassing. Besides satisfying the diversity criteria, the segments need to have approximately equal birth rates. Leet and his project manager, Amanda Harrod, have been studying birth data from St. Louis city and Macoupin County to define their target segments.

Once the geographical segments have been randomly selected using statistical methods developed by National Children’s Study statisticians at headquarters in Washington, recruiting will begin. Field workers trained by Battelle will go door to door, identifying women either early in a pregnancy or who intend to become pregnant. As these women join the survey, they will start keeping a diet diary, and the interviewers will begin to collect data on their physical health, mental health and environmental exposure.

“Recruiting mothers before conception, or in very early pregnancy, means we can measure environmental influences when the fetus is still forming,” says Louise Flick, DrPH, co-principal investigator from SIU-Edwardsville School of Nursing. Flick is especially interested in the relationship between mental illness and the persistent use of tobacco during pregnancy. “Is smoking a way of self-medicating their symptoms?” she wonders. She will apply for a special grant to pursue this problem with the mothers in the local study areas.

Flick was attracted to the study because she is the daughter of a schizophrenic mother, and has been especially interested in psychiatric illness and its effect on the child. Her role in the Gateway Study Center is to be the coordinator in the collection of birth data from 17 hospitals in three counties.

What is the birth data to be collected for each baby?

  • Biological samples: maternal blood, newborn blood, placenta, umbilical cord, cord blood, and meconium, all to be stored at the national repository
  • Interviews: A short interview of the mother at birth
  • Newborn examination data: neurological exam, behavioral characteristics, birth defects
  • Record Extraction: Birth weight, Apgar score

To collect such a wealth of data will require lots of cooperation from the medical community. Flick and her colleagues, including co-principal investigator Dr. Allison King from Washington University School of Medicine, are busily educating hospitals, pediatricians, and obstetricians about the importance of the study to the health of future generations. They need to devise protocols to get all the information while keeping delivery rooms running smoothly. They need to get the doctors and nurses on board.
Prenatal and birth data from 100,000 babies will available by 2016, if all goes as planned. Kristen Heffington is one mother who will be looking forward to reading about it. Now the mother of 2-year-old son Cole, she had previously lost twins born 16 weeks premature. She is acutely aware of the value of research because the March of Dimes helped her bring Cole to near term. She is pregnant again, and with the help of a new drug that the March of Dimes helped to develop, hopes to have the next baby at full term.

At the end of the study, the file of each 21-year old will be inches thick. In that file will be several prenatal interviews and samples, birth data and samples, interviews and samples from child, mom, and dad twice yearly until the third birthday, and once a year thereafter. Mom will keep track of the family diet. Environmental samples will be taken not only from the home, but from daycare, school and perhaps even summer camp.

What would persuade a family to enroll in such a program? Most will probably do it simply for the good of their children and their children’s children. Leet points out that many parents participate voluntarily in diet surveys conducted through universities. A truly effective example of parent cooperation is described in the related story on the St. Louis Baby Tooth survey of the 1950s and 1960s.

There will be a slight financial inducement also. Families will be paid about $25 for each interview, and $100 for each collection of biological samples.

Analyzing and using the data

As it is collected, medical and interview data will be organized. Biological and environmental samples will be stored.

Grants will be awarded for analyzing the data. A hypothetical request for proposals that might go out as birth data collection draws to a close could deal with autism. Since autism can now be diagnosed as early as 18 months, samples from these autistic children could be examined for candidate environmental contaminants. Or medical histories may be mined for correlations between infections contracted by the mother during pregnancy and the development of autism. For example, of all the mothers who developed strep infections when pregnant, how many had autistic children? Sample sizes will be large enough to be meaningful.

Data collection will not be complete until 2034. Who knows where science will be by that point? Analytical capabilities will surely be more sensitive. The Human Genome Project will have yielded more leads to the genetic causes of disease.

And this study will have the materials to begin to make connections between genetics and the environment in the development of human disease.

A sample hypothesis

Taken from the National Children’s Study website:
“Among women without diabetes before pregnancy, impaired glucose metabolism during pregnancy is associated with risk of major congenital malformations of the heart, central nervous system, musculoskeletal system, and all birth defects combined.”
Jo Seltzer is a freelance writer with more than 30 years on the research faculty at the Washington University School of Medicine and seven years teaching tech writing at WU's engineering school. 

Jo Seltzer