Speaker's Prepared Remarks

Eunice Kennedy Shriver
National Institute of Child Health and Human Development
National Institutes of Health

National Children’s Study Announcement of Study Launch

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, and representatives from two study centers participating in the National Children’s Study.

• Dr. Duane Alexander, Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, who will present a brief update on the status of the National Children’s Study
• Dr. Peter Scheidt, Director of the National Children’s Study, who will describe the next steps that the study will take
• Dr. Barbara Entwisle, of the Carolina Population Center of the University of North Carolina at Chapel Hill, and
• Dr. Philip Landrigan, Mount Sinai School of Medicine in New York

Dr. Duane Alexander

Good morning. Thank you for joining us for another in our continuing series of periodic updates on the progress of the National Children’s Study. It’s not an accident that I use the term “progress.” I’m happy to report that after 8 years of intensive research and planning, the National Children’s Study will recruit its first volunteer study participants. We will be examining the interaction of genetics and the environment and their effects on children’s health and development. We want to study the earliest possible environmental exposures to children. So we will begin with recruiting and enrolling women who are in the early stages of their pregnancies and, in some cases, women who are not yet pregnant. We’ll follow the women throughout pregnancy, eventually checking in on the children they will one day bear. We’ll conduct periodic evaluations, during pregnancy, at birth, through childhood, and on to the children’s 21 ^st year. At each stage, we’ll look to unravel the complex relationships between genetics, a broad range of environmental exposures, and the children’s health and development. The study will investigate factors influencing the development of conditions such as autism, cerebral palsy, learning disabilities, birth defects, diabetes, asthma, and obesity.

The National Children’s Study was mandated by the United States Congress, in the Children’s Health Act of 2000. Congress authorized the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health to lead a consortium of agencies in the study. The NICHD’s partners in conducting 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.

The hard work of the study’s scientists and advisors has produced a large, national, comprehensive study that will monitor the health of 100,000 American children as they grow to adulthood. Although other nations have embarked on similar undertakings, the National Children’s Study is uniquely American in its scope. The land that would become the United States of America was already inhabited when Europeans first came in contact with it. Since then, it has been settled by virtually all of the world’s people. To be truly representative of the nation as a whole, the National Children’s Study had to devise a sampling plan that would encompass this diversity. Study scientists have identified a total of 105 U.S. locations–mostly counties–from which to recruit participating families. These study locations were scientifically chosen to provide a representative sample of America’s racial and ethnic diversity, of rural, urban, and suburban communities, and of families from all economic levels.

Study scientists will collect biological samples as well as samples from the environment—air, water, and even house dust.

The principal benefit of a large scale, long-term study like the National Children’s Study is that it will uncover important health information at virtually every phase of the life cycle. Initially, it will provide major insights into disorders of birth and infancy, such as preterm birth and its health consequences. Ultimately it will lead to a greater understanding of adult disorders, many of which are thought to be heavily influenced by early life events..

We believe that what we learn from the National Children’s Study will result in a significant savings in the Nation’s overall health care costs.

Currently, there are 36 study centers that will serve 72 study locations. When it is fully operational, we expect the National Children’s Study to have about 40 study centers recruiting volunteers from each of the 105 study locations throughout the United States.

Today, however, we will talk about the upcoming activities of just two of those National Children’s Study centers: the University of North Carolina at Chapel Hill and the Mount Sinai School of Medicine. Researchers at these centers are poised to begin the initial contact with prospective volunteers in the study locations they serve. This month, they will recruit women for the initial, or pilot, phase of the study.

Now I’d like to take a moment to avoid a misconception. The term “pilot study” usually refers to an early, or preliminary, study undertaken to test the study’s methods and systems to make sure they all work well and the study operates smoothly. In this case, however, the National Children’s Study researchers also are using the term to describe the beginning phase of the complete study.

Please let me introduce the Director of the National Children’s Study, Dr. Peter Scheidt, who will describe the study’s imminent launch in more detail.

Dr. Scheidt

Thank you, Dr. Alexander. I think it will help to explain what we mean by the term “pilot study,” if I could draw upon an analogy. Beginning the National Children’s Study is like building a pine wood model car for competition in a child’s miniature racing competition, or any similar project. You wouldn’t just build the car and directly enter in the competition. You would first try it out under the conditions you would expect to find, checking to be sure it was in good working order and performed as you planned. So for the National Children’s Study, we’re going to embark on an initial round of enrollment and data collection. We’ll look at what we’ve accomplished, see if our recruitment efforts were successful, see if our sampling methods were sufficient, and if we’ve otherwise asked the right questions to get the information we need. Along the way, we’ll undertake any fine tuning that we need to in preparation for enrollment after the pilot phase. Because this phase of the study is being under taken by our initial, or Vanguard, study centers, we also refer to it as the study’s Vanguard phase.

The pilot, or Vanguard phase will last for 18 months. During that time investigators from the University of North Carolina at Chapel Hill will contact women in Duplin County, North Carolina, the study location served by the UNC study center. The women will be selected from predetermined geographic areas, or segments as they are called, of that study location. They will receive a letter describing the study, after which they will be contacted again and asked if they would like to participate. Area prenatal care providers will also assist us in reaching women who may be missed by the household recruitment. Medical staff at the prenatal care clinics will explain the study to women who come in for prenatal care, and inform them of the opportunity to participate and ask if they’d like to participate.

During this time, National Children’s Study researchers at the Mount Sinai study center will also begin the process in the study location of Queens, New York. The process will be essentially the same, with study staff contacting area women by letter, and with area prenatal clinics informing the women about the study. In all of the study locations, extensive efforts will be taken to inform the local communities about the National Children’s Study so that as many women as possible will know about the Study before it begins.

In April of 2009, other centers will begin recruiting. The University of North Carolina and Mount Sinai are two of 7 Vanguard Centers for slated to begin the study. The remaining 5 Vanguard centers will each recruit about 310 study volunteers. As the Vanguard pilot phase continues, we’ll go over what we’ve learned, examine our data collection and recruitment methods, and see whether and how we might need to refine our methods before beginning the full study. We anticipate that at the end of 18 months, each center will have recruited approximately 375 study volunteers.

Let me stop here for a clarification. At the National Children’s Study, we often receive calls from community officials, University faculty and others asking if their communities can be part of the National Children’s Study. Similarly, women also contact us about volunteering for the study.

I have to explain, that unfortunately, you can’t be admitted to participate in the National Children’s Study by volunteering as an individual or volunteering your community; we have to contact you. It’s very important that the study be representative of the nation as a whole or else the information we obtain will not adequately represent the experience of our children nationally. To achieve this representation, we had to carefully select the study locations from which we’ll be recruiting, in advance. Similarly, researchers at the study centers will try to recruit volunteers from the communities or segments of the locations or counties in a way that maintains that representative context of the study. They already know which communities and neighborhoods they need to recruit from.

In conclusion, the launch of the National Children’s Study is a major milestone. It is very exciting to reach the point at which we’re beginning enrollment and data collection. Findings from the study will ultimately benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments and perhaps even cures for disease. As we mark the beginning of this ambitious study, it is appropriate to recognize that the National Children’s Study belongs to all of us—scientists, communities, and families.

So having provided a basic explanation of the initial phase of the study, I’d like to next introduce the Principal Investigators from the University of North Carolina Center, Dr. Barbara Entwisle and from the Mount Sinai Center, Dr. Philip Landrigan. They will each take a few minutes to tell us about their Center’s role in the study.