Mark Your Calendars
Join us for the next Study Assembly meeting on "Implementing the National Children's Study: Scientific Progress, Challenges, and Opportunities," November 29-30, at the Omni Shoreham Hotel in Washington, DC. Study Assembly meetings are open to anyone from the scientific community and general public who is interested in learning more about the progress of the Study.
National Children's Study planners have been investigating children's health issues; developing the Study design for framing the Study; and developing partnerships with scientific, community, and other non-governmental organizations. This preparation has resulted in significant progress in laying the groundwork to engage a broad range of the American population in the Study. This Study Assembly meeting will focus on scientific progress to date, introduction of the Vanguard Centers and Coordinating Center, and the challenges and opportunities in this unprecedented study of the effects of the environment on child health and development.
National Children's Study Federal Advisory Committee Meetings Resume
The National Children's Study Federal Advisory Committee (NCSAC) met on April 27–28 to discuss the progress of the Study, focusing on the roles of NCSAC members, the importance of community engagement and partnerships, and next steps in the Study implementation.
Alan Fleischman, MD, chair of the NCSAC, emphasized to the committee members their role as Study advisors, which is to offer recommendations to Study leaders and listen to concerns of the scientific community and the public. Recognizing the need for cultural sensitivity in all aspects of the Study, NCSAC members discussed how acceptance of ethnic differences and divergent beliefs will continue to be an overarching theme in their work and that of the new subcommittees. It is further hoped that these subcommittees—on Concept Review, Ethics, Community Involvement, and Technology—will enhance NCSAC productivity and enrich future discussions.
In recognition of past members, Duane Alexander, MD, director of the National Institute of Child Health and Human Development, presented service awards to former NCSAC leaders Donald Mattison, MD (former chair) and Jan Leahey (former executive secretary) to honor their contributions to the committee.
As the topic turned to community engagement, Giselle Corbie-Smith, MD, MSc, associate professor, Sheps Center for Health Services Research at the University of North Carolina, discussed research findings on the value of community collaboration, ethical considerations, and the role of Community Advisory Boards in environmental health research.
According to Sarah Keim, MA, study coordinator, "the very success of the Study will depend on the active engagement of communities." Ms. Keim described the Study's past and current outreach activities, including focus group research to understand concerns of health care providers and community groups, contact with national and local organizations, and the development of communication tools to help inform the public about the Study. The National Children's Study will direct Study Centers to conduct individualized community needs assessments and implement strategies to ensure community concerns are addressed. The NCSAC noted the importance of providing the centers sufficient time and funding to allow for vigorous engagement of communities.
Marion Balsam, MD, director of the National Children's Study Research Partnerships Program, emphasized the key role that outside organizations will play in Study implementation, with an overview of the benefits and ethical considerations of public-private partnerships. The primary focus of this segment was on the issue of incentives to enhance recruitment and retention and the concerns that incentives ought not be an undue inducement to participation or so large as to be coercive.
Several nonprofit and health organizations are working to help raise awareness about the Study among their members. Representatives from the American Association on Mental Retardation, the Children's Environmental Health Network, and the Society for Maternal-Fetal Medicine spoke enthusiastically about their support of the Study's efforts to date.
Pauline Mendola, PhD, a member of the Interagency Coordinating Committee, provided an overview of a pilot study in North Carolina that will test some of the sampling, recruitment, and data collection methods planned for use in the National Children's Study. The results of this project, called the "Herald Study," will assist the Vanguard Centers in finalizing the Study protocol and initiating community engagement activities.
Looking ahead, the NCSAC plans to play a role in the translation of Study findings into local and national action. "Study findings will be available in two to three years after the Vanguards are up and running. Armed with these data, we will hope to work toward fulfilling the great potential of the Study to enhance the well being of children," said Dr. Fleischman.
Are Practice-Based Research Networks Suitable to Serve as National Children's Study Sites?
The National Children's Study planners and the Agency for Healthcare Research and Quality recently studied whether medical practice settings would be suitable sites for participant assessment and data and specimen collection for the National Children's Study. Practice-Based Research Networks (PBRNs) are ambulatory care practices that affiliate with each other, and often with an academic center, in order to conduct research. Because PBRNs already have an understanding of research and have established ties with women and children in their communities, they were used to address this question regarding the use of practice sites in the National Children's Study.
The PBRN pilot study was conducted in two phases. Phase 1, completed in September 2003, found that PBRNs were interested in participating in the Study. Phase 2, completed in December 2004, assessed PBRN capability to carry out a facsimile of the Study Protocol. During this latter phase, PBRNs performed interviews, exams, and assessments, which they completed at high rates. For example, on average, medical and dietary histories were 87% complete.
Concerns expressed by PBRNs included collecting, handling, and storing urine samples (these were collected for only 74% of participants), as well as managing scheduling, time, and office space when seeing pilot study participants and routine care patients at the same time. Some of these logistical difficulties can be minimized, however, according to Marion Balsam, MD, who managed the pilot study on behalf of the Program Office. "Increased infrastructure support for all Study Centers will be available when the full Study gets off the ground," she said.
A follow-up survey to further assess the degree of interest of PBRN physicians was recently conducted. Though the small number of returned questionnaires limits the ability to interpret this data—only 39 of the 159 physicians (25%) responded—the majority of the pediatrician respondents indicated their willingness to follow over 15 Study participants at a given time. The majority of obstetricians who responded were willing to follow up to 30 per year.
Good to Know
The Air Children Breathe
Children may be especially susceptible to adverse effects from air pollution since their lungs are still developing. Breathing air that contains substances such as fine particulates, ozone, nitrogen oxides, and tobacco smoke during critical windows of development can be especially harmful and have long-term adverse effects, such as reduced lung volume. The information on toxicity of many airborne chemicals—such as metals—is sparse.1 Childhood asthma is the most disabling disease of childhood, affecting about 1 in 10 U.S. children, but how and why it develops is not yet fully understood. Recent findings raise important questions about how exposure to air pollution affects children into adulthood and why some children are more vulnerable than others, which the National Children's Study will investigate.
In a recent study that suggests air pollution can inhibit normal lung development, researchers at the University of Southern California followed about 1,800 children from 10 to 18 years of age and measured their lung function via spirometry. They also measured levels of airborne pollutants such as fine particulate matter (PM2.5) and nitrogen dioxide. The investigators found that current levels of ambient air pollution can have chronic, adverse effects on lung development, leading to clinically significant deficits in lung capacity as these children reach adulthood.2 While this study began enrolling children at an average age of 10, the National Children's Study will begin monitoring children from before birth through age 21, offering the possibility of demonstrating even more far-reaching effects and more refined measures of exposures to pollutants such as indoor allergens, endotoxin, and tobacco smoke.
Another recent study in New York City found that exposure to certain volatile compounds in the air could lead to genetic alterations in the fetus. The 60 women enrolled in the study carried personal air monitors during the third trimester of pregnancy which measured the level of airborne substances including polycyclic aromatic hydrocarbons (PAHs)—carcinogens generated by combustion sources such as vehicle exhaust and tobacco smoke. Using cord blood measurements, exposure to PAHs was correlated with alterations in the baby's chromosomes that are considered a biomarker for increased cancer risk.3
Exposure of children to elevated levels of air contaminants can occur in a variety of settings. For example, a recent pilot study using an exhaust system tracer gas (sulfur hexafluoride) in six school buses measured higher levels of pollutants inside the vehicles than outside, apparently due to leakage of exhaust fumes.4 About 24 million U.S. children ride more than 600,000 buses each school day, and this study suggests that some passengers may be exposed to elevated levels of diesel exhaust that is classified as a probable human carcinogen.5
Airborne agents such as particulates, nitrogen dioxide, and PAHs are among the many environmental factors the National Children's Study will measure in the environment of 100,000 children, following those children into adulthood. This type of large-scale study can provide objective data for determining how to protect our children from harmful substances in the environment.
- Kim JJ. Ambient air pollution: Health hazards to children. Pediatrics 2004;114(6):1699-1707.
- Gauderman WJ, Avol E, Gilliland F, et al. The effect of air pollution on lung development from 10 to 18 years of age.
N Engl J Med 2004;351(11):1057-1067.
- Bocskay KA, Tang D, Orjuela MA, Liu X, Warburton DP, Perera FP. Chromosomal aberrations in cord blood are associated with prenatal exposure to carcinogenic polycyclic aromatic hydrocarbons. Cancer Epidemiol Biomarkers Prev 2005; 14(2):506-511.
- Marshall J, Behrentz E. Vehicle self-pollution intake fraction: Children's exposure to school bus emissions. Environ Sci Technol [serial online] 2005 [cited June 3, 2005]; 39(8), 2559-2563. Available from URL: http://pubs.acs.org/cgi-bin/
- Wargo J. Children's exposure to diesel exhaust on school buses. Environment and Human Health, Inc.; 2002.
Comments or Questions?
Visit our Web site at http://nationalchildrensstudy.gov
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