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Looking Back at 2005, Looking Forward to 2006
2005 marked a significant milestone in the life of the National Children's Study, most notably with the announcement of the first Centers that will launch and carry out the Study in seven communities across the country.
 Vice Admiral Richard H. Carmona, MD, MPH, FACS, U.S. Surgeon General, joined Duane Alexander, MD, Director of the National Institute of Child Health and Human Development, and representatives from other leading federal agencies and national health organizations at a press conference in Washington, DC to announce the awarding of the initial Vanguard Centers and Coordinating Center this past September.
In the months following the announcement, state officials, Study planners, local leaders, parents, and children gathered in their communities to celebrate the launch of the Centers in the seven Vanguard sites.
Vanguard Centers began study planning well before the awards. Now, building and training staff, setting up advisory committees, and establishing systems to support enrollment and data collection are among the many activities on the horizon. In the near future, the Centers will engage in full community needs assessments, work closely with the National Center for Health Statistics on sampling, and assist the Program Office in refining the Study Protocol.
Study Protocol
The Study Plan, a broad outline of the Study, was unveiled in November 2004. Study planners are currently developing the Study Protocol, a roadmap to guide researchers' sampling, recruitment, and data collection activities. The protocol will specify details of the second–stage sampling, including how Study sites will be divided into smaller geographic areas (segments) and how these segments will be selected. Segments will be the specific geographic areas in each participating county from which Study participants will be recruited. The protocol will also detail the data collections that will take place at each of the scheduled visits in home and clinical settings.
"Now that the Vanguard Centers have been selected, we can benefit from their input on defining neighborhoods, and other Study parameters," said Ruth Brenner, MD, MPH, Director of Protocol Development at the Program Office. The Program Office plans to have the protocol completed by the spring of 2006.
Pilot Studies
Pilot studies that are field-testing procedures and technologies to be used in the National Children's Study continue on schedule. Planners of a North Carolina pilot study for the National Children's Study have completed that study's protocol, including the delineation of neighborhoods in its two counties (one rural, one urban), and have prepared to collect biological and environmental data. This children's environmental health study will act as a prototype for the National Children's Study and will begin recruitment this year. Study planners hope to enroll approximately 900 women who are currently pregnant or who may become pregnant during the study timeframe.
Other Activities
Study leaders continued discussions on ethical issues and other key Study considerations at the National Children's Study Federal Advisory Committee (NCSAC) meetings in April and September of 2005. Committee members offered input on recruitment incentives, methods for informing participants and communities about Study findings, and ways to ensure community engagement. The NCSAC met again on January 24-25, 2006 to make recommendations about the science and design of the Study.
Public interest in the Study continues to grow. Throughout 2005, the Program Office shared information about the Study with national child and environmental health organizations, which conveyed that information to their members and constituents across the country. In addition, news reports in 2005, with newspaper, television, and radio coverage, focused mainly on the announcement of the Vanguard Centers and Coordinating Center in September.
As the National Children's Study looks ahead to this year, growing public interest in the Study and community engagement in the Vanguard sites will help lay the groundwork for one of the next steps in implementation: recruitment. As National Children's Study Director Peter Scheidt, MD, MPH, emphasized at the November 2005 Study Assembly meeting, "The pieces are in place to move forward. To do so, we must continue to build the science, build relationships with the community, and begin enrollment and data collection in the Vanguard Centers. We must continue to lead the Study with steadfast momentum, while being flexible to accommodate what we learn along the way."
National Children's Study Assembly Meeting Focuses on Scientific Progress, Challenges, and Opportunities in Implementation of the Study
More than 300 members of the National Children's Study Assembly gathered in Washington, DC on November 29–30, 2005, to learn about progress in implementing the National Children's Study, to exchange ideas, and to discuss scientific progress, challenges, and opportunities in Study implementation. Federal leaders; representatives from national organizations and local health departments; Vanguard Center and Coordinating Center staff; and members of the medical community, universities, and the general public attended the fifth Study Assembly meeting.
"This meeting comes at a strategic juncture in the Study, at the intersection of planning, establishing the first Study Centers, and making preparations for the remaining Centers," said Peter Scheidt, MD, MPH, Director of the National Children's Study, who gave an overview of Study progress to date and introduced the Coordinating Center and Vanguard Center principal investigators (PIs). The Vanguard Center PIs provided a descriptive snapshot of the Study communities, giving the Study Assembly its first look at the rural, urban, and suburban counties that will host the Study. The Coordinating Center PI discussed the strategies for organizing and coordinating the multitude of activities necessary to carry out the Study.
During the two-day meeting, Study leaders offered updates on other major activities, including pilot studies, workshops, and protocol development. Participants engaged in discussions in small breakout sessions on chemical and physical exposures, biological and psychosocial exposures, pregnancy and neurodevelopmental outcomes, community engagement, data collection, and international collaboration initiatives. Other topics that provided a forum for discussion included the ethics of research with children, how to combine both a biomedical and psychosocial focus in the same study, and how to conduct a birth cohort study in a probability sample of the U.S. population.
Community engagement emerged as a major theme and a task that represents both a challenge and an opportunity for the Study. "Involving community leaders is essential in recruitment and retention. They can help us introduce the Study to residents, and help guide us on issues like the appropriateness of incentives. Community engagement can also benefit communities, bringing opportunities for capacity-building among neighborhood groups who may not be talking to each other," said Edith Parker, DrPH, Associate Dean for Academic Affairs at the University of Michigan School of Public Health.
Regina Shih Joins the National Children's Study Program Office
Regina Shih, PhD, has joined the National Children's Study Program Office as an Intramural Research Training Award (IRTA) Post-Doctoral Research Fellow. At the Program Office, Dr. Shih will help with protocol development, specifically with regard to neurodevelopmental outcomes and environmental exposures. Prior to joining the Study, she was a National Institute of Mental Health Psychiatric Epidemiology Pre-Doctoral Research Fellow in the Department of Mental Health at the Johns Hopkins Bloomberg School of Public Health.
Dr. Shih recently completed a doctoral degree in public health, with a focus on mental health epidemiology from Johns Hopkins. Her dissertation investigated recent and cumulative lead doses as risk factors for abnormal neurobehavioral functioning. Dr. Shih became involved in the National Children's Study because she enjoys the challenge of disentangling the effects of social, cultural, genetic, and biological factors on child development. She looks forward to helping design the Study's rigorous interdisciplinary approach to studying children's environmental health.
The Persistence of Stress
Excessive prenatal stress has been associated with adverse pregnancy outcomes such as preterm delivery and with long-term psychological and behavioral disturbances such as attention deficits and depression. A disturbance in neuroendocrine functioning—particularly in the hypothalamic-pituitary-adrenal (HPA) axis, which controls the body’s stress-related hormones—is a possible mediating mechanism. Several researchers hypothesize that the cortisol released by stress crosses the placenta in a pregnant woman and disrupts development of the fetal HPA axis.
Preterm delivery, the largest single cause of neonatal death, received particular attention in a recent review,1 which posited that stress might disrupt neuroendocrine mechanisms that are related to the risk of preterm delivery. Stress due to poverty, racism, and unsafe neighborhoods might explain at least some of the higher risk of preterm delivery among minority women. Another study, the first to investigate the link between prenatal anxiety and HPA dysfunction in humans past infancy, found that anxiety in pregnancy predicted elevations in cortisol among the offspring more than a decade later.2 Researchers at the University of Rochester Medical Center measured salivary cortisol, a common index of HPA functioning, in 74 10-year-old children. Prenatal anxiety was significantly positively associated with cortisol levels in children, with the strongest association observed for anxiety in late pregnancy (32 weeks' gestation) and for cortisol in the children when they awoke.
The effects of prenatal anxiety on children’s HPA axis functioning may make children more vulnerable to the influence of future life stress and to the development of dysfunction. But multiple questions remain. Among them are uncertainty about what the significance of cortisol is and about what other effects sympathetic arousal during pregnancy might have on the infant. Findings from the National Children’s Study will help answer these and other questions about prenatal stress, neuroendocrine functioning, and behavior, and may even revolutionize how we care for the mental health needs of pregnant women.
1. Rich-Edwards JW, Grizzard TA. Psychosocial stress and neuroendocrine mechanisms in preterm delivery. Amer J Obstet Gyn 2005;192(5 Suppl):S30–S35.
2. O'Connor TG, Ben-Shlomo Y, Heron J, Golding J, Adams D, Glover V. Prenatal anxiety predicts individual differences in cortisol in pre-adolescent children. Biol Psychiatry 2005;58:211–17.
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The National Children's Study is led by a
consortium of federal agency partners:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY
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