Eunice Kennedy Shriver
National Institute of Child Health and Human Development
National Institutes of Health
National Children’s Study
Announcement of New Study Centers
October 3, 2008
Participants
Duane Alexander, M.D., Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health
Peter Scheidt, M.D., M.P.H., Director, National Children’s Study (NICHD)
Moderator: John McGrath, Ph.D., Chief Public Information and Communications Branch, NICHD
John McGrath: Welcome to this briefing on the National Children’s Study. I’m John McGrath, Chief of the Public Information and Communications Branch at NICHD, and I will moderate today’s call. Here with me today are two representatives of the Eunice Kennedy Shriver National Institute of Child Health and Human Development:
- Dr. Duane Alexander, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, who will present an overview of the National Children’s Study and announce the names of the new Study Centers
- and
- Dr. Peter Scheidt, Director of the National Children’s Study, who will provide a brief chronology of the Study and details about the next steps in its implementation.
And now, I would like to introduce Dr. Duane Alexander, the Director of the NICHD.
Dr. Duane Alexander: Good morning. Thank you for joining us. We’re here to announce 39 new locations and 27 study centers for the National Children’s Study. Periodically, we provide you with updates on the study’s progress. Many of you have been with us before, for earlier announcements. I’ll provide a crash course for those who are new and a review for those who have been with us before.
The study will begin by recruiting women before they give birth—and in many cases, before they conceive their children. Study scientists will follow the children that these women give birth to until they are 21 years of age, monitoring their health and development closely from early infancy, on through childhood, and into young adulthood. Eventually, 100,000 children will take part. The National Children’s Study will encompass a nationally representative sample, designed to be a composite of the U.S. population. It will include children throughout the United States, from rural, urban, and suburban areas, from all income and educational levels, and from all racial groups.
The National Children’s Study began with the Children’s Health Act of 2000, which authorized the Eunice Kennedy Shriver National Institute of Child Health and Human Development and a consortium of federal agencies to conduct the National Children’s Study. Partnering with NICHD to conduct the National Children’s Study are the NIH’s National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency. Since preparations for the study began in 2000, researchers affiliated with it have been devising the methods needed to conduct the study. They’ve been deciding what kinds of samples they’ll need to collect, the means to analyze those samples, and how to develop ways to recruit a population of study volunteers that is representative of the population of the United States in all its social, geographic, economic, and racial diversity.
In 2004, we identified 105 U.S. communities from which we would recruit and study participating families. Our first major announcement on the study’s progress was the awarding of contracts for the Vanguard Centers in 2005. These were the initial study centers, and will be the first centers to recruit volunteers for the study. The Vanguard Centers will also test the research methods we need to conduct the larger study. In 2007, we added an additional 17 new study centers. Each of the study centers will recruit volunteers from the study locations they manage.
The researchers at the centers will collect biological samples as well as samples from the women’s and children’s environment—air, water, and even house dust. They’ll collect samples of the materials used to construct homes and schools to see whether these and other environmental factors influence the children’s health.
In its national scope, in the number of children it will follow, in its focus on development from infancy through adulthood, the National Children’s Study is unique. There is no other American study quite like it. We look to it to provide new information that will help treat and perhaps even prevent any of a range of adult conditions that have roots in childhood: asthma, autism, attention deficit disorder, learning disabilities, mental health problems, obesity, diabetes, high blood pressure, and heart disease. We anticipate that, in the long term, what we learn from the study will result in a significant savings in the nation’s health care costs.
According to one estimate, just six of the conditions that the National Children’s Study will look at—obesity, injury, asthma, diabetes, schizophrenia, and autism—cost the United States $758 billion per year. Estimating conservatively, if what we learn from the National Children’s Study results in only a 1 percent reduction in the cost of these conditions, our nation will save about $7.58 billion a year. That one-year saving is more than double the entire $3.2 billion the National Children’s Study is expected to have cost when the children who participate reach 21 years of age.
In explaining the promise of the National Children’s Study, we often talk about the study’s potential to provide information on conditions that manifest themselves in adult life. But we won’t have to wait 21 years before we see results. Because the study follows children from before birth through adulthood, we expect it to yield information along each step of the developmental process, from infancy, through early childhood, the preteen and teen years, and again in early adulthood.
Today, we’ve reached a turning point. For 2008, a total of 27 study centers have been funded. Some of these have been funded in previous years. We’ve posted a listing of the 2008 centers and their corresponding locations in our news release on the NICHD Web site, at www.nichd.nih.gov.
Today’s announcement brings the total number of new and previously funded study centers to 36.
Contracts have been awarded to the study centers we’re announcing today, based on rigorous criteria. They have demonstrated a strong ability to collect information for the study, the ability to inform their communities about the study, to recruit eligible women, and for devising plans to retain the women and their children until the children reach 21 years of age. They have also demonstrated a strong capacity to protect the privacy of the study participants. All participants will remain anonymous.
Progress of the National Children’s Study is always contingent upon funding, which is approved by Congress on a yearly basis. With that in mind we anticipate that the study will start recruiting the first volunteers in early 2009.
Having introduced the study to those who are not familiar with it, and reviewed it for those who have attended our earlier briefings, I’ll announce the names of the 2008 study centers and their locations. After that, the Director of the National Children’s Study, Dr. Peter Scheidt, will talk about the study’s immediate future and its projected launch in 2009.
The study centers funded in 2008 are: [The speaker referenced the centers listing at http://www.nichd.nih.gov/centers2008/. ]
Dr. Peter Scheidt: Thank you Dr. Alexander. We now see the light at the end of the tunnel. We anticipate that the National Children’s Study’s Vanguard Centers will begin recruiting for the pilot phase of the study in January of 2009. The Vanguard Center at the University of North Carolina at Chapel Hill will begin recruiting in Duplin County, North Carolina, and the Vanguard Center at the Mount Sinai School of Medicine will begin recruiting in Queens, New York. I’d like to emphasize that this will be for the pilot phase of the study. That’s the very early phase of the study in which we test the recruitment and sampling methods we’ve developed, to see if they work as well as we believe they will.
I have to add a caveat here. As Dr. Alexander pointed out, our funding is allocated by Congress each year. Again, let me remind you that all the projections we’re making today are contingent on yearly funding renewals.
We project that in April 2009, the remainder of the Vanguard Centers will continue the recruitment for pilot testing, at locations in California, Pennsylvania, South Dakota, Minnesota, Utah, and Wisconsin. I won’t name all the remaining centers and locations here. They’re available on the study’s Web site, www.nationalchildrensstudy.gov. “National Children’s Study” is all one word, and there’s no apostrophe before the “s” in “children’s.”
After we complete the pilot testing, we expect to begin recruiting for the full study in three waves, beginning in July 2010, again in July 2011, and finally, in July 2012.
A minimum of 250 live births are expected in each of the study locations, for each of four years.
Currently, the established centers are hiring and training staff, meeting with local community groups and health care professionals to inform them about the Study, and establishing community advisory boards to provide ongoing guidance on a range of Study-related issues.
In the past, we’ve talked about the study following the children through their 21st birthday. Right now, I’d like to stress the study’s short term benefits. With more than 100,000 participants, we believe the National Children’s Study will be the largest study of pregnant women ever conducted—certainly the largest such study conducted in the United States. We expect the study to yield information on a variety of pregnancy and birth-associated conditions.
Paramount among the conditions we need to learn more about is preterm birth. According to findings from the Surgeon Generals conference on preterm birth last summer, every year, nearly 500,000 American babies are born too soon. More than 12 percent of U.S. births are preterm. This rate has been rising steadily in recent years. Because of advances in research and health care, many preterm babies survive and do well. However, a sizeable number of them are at risk for serious complications, some of which may be life-long. Preterm infants are at risk for early death. Some don’t survive the newborn period. They’re at increased risk for Sudden Infant Death Syndrome—unexplained death in the first year of life. They’re also at increased risk for cerebral palsy, mental retardation, learning disabilities, visual difficulties, and hearing problems. Low birthweight infants who reach adulthood are at increased risk for obesity, high blood pressure, heart disease, and diabetes, conditions which all reduce the quality of life, contribute to health care costs, and rob many people of productive years of life.
The costs associated with prematurity are substantial. The estimate from the Surgeon General’s conference was $26 billion per year.
We look to the National Children’s Study to provide information that will be helpful in reducing the proportion of preterm births and their considerable economic and personal costs. It will document 100,000 pregnancies. This will include genetic samples from the women and their infants, information on their diets, possible exposure to chemicals in their environments, and their emotional stress levels. So while we’ve talked about the long term benefits of the study, we can expect some fairly short term benefits as well. We expect that what we learn from the National Children’s Study will provide new information that we can use to begin solving the problem of preterm birth. We are hopeful that we will have this information in just a few years.
Thank you very much.
Dr. McGrath:
We will now take questions from our callers. Operator, would you please provide instructions to our listeners at this time?
