September 29, 2005 — The National Children’s Study-planned to be the largest study ever undertaken to assess the effects of the environment on child and adult health-took a major step forward today with the announcement that contracts have been awarded to 6 Vanguard Centers to pilot and complete the first phases of the Study.

Salt Lake County was named a Vanguard Center, and the University of Utah School of Medicine Department of Pediatrics, with support from Primary Children’s Medical Center and other government and health care groups, has been awarded a $16 million contract to fund the study.
Principal investigator for the Salt Lake County study is Dr. Edward Clark, chair of the University’s Department of Pediatrics and medical director of Primary Children’s Medical Center.

“This is an extraordinary opportunity to invest in our children,” says Dr. Clark. “I can’t think of anywhere else in the country where the population is more focused on the future of children.”

The full Nationwide Study would follow a representative sample of children from early life through adulthood, seeking information to prevent and treat such health problems as autism, birth defects, diabetes, heart disease, and obesity. The announcement was made today at a news briefing in Washington, D.C., by the National Institutes of Health, one of the agencies sponsoring the study.

Dr. Clark expects that 1,250 individuals in Salt Lake County will be enrolled in the study by 2009, with selection beginning in July of 2007.

As the study progresses, approximately 90 persons will be hired to support the 16 investigators, who represent a broad spectrum of disciplines, including pediatrics, obstetrics, psychology, environmental science, education and others.

Utah Governor Jon M. Huntsman, Jr., said, “This is a unique opportunity and a great recognition of the exceptional pediatric science and care we have in Utah. The University of Utah Department of Pediatrics and Primary Children’s Medical Center are the best possible venues for this study to begin. No other community has a greater love for children. I congratulate the University Department of Pediatrics for this honor, for which Utah is well suited.”

“The National Children’s Study would follow more than 100,000 children, from before birth-and, in some cases, even before pregnancy,” said Duane Alexander, M.D., Director of the National Institute of Child Health and Human Development, one of the National Institutes of Health. “It would meticulously measure their environmental exposures while tracking their health and development, from infancy through childhood, until age 21, seeking the root causes of many childhood and adult diseases.”

In the search for environmental influences on human health, and their relationship to genetic constitution, National Children’s Study researchers plan to examine such factors as the food children eat, the air they breathe, their schools and neighborhoods, their frequency of visits to a health care provider, and even the composition of the house dust in their homes. Study scientists also plan to gather biological samples from both parents and children and analyze them for exposure to environmental factors.

The planned National Children’s Study is led by a consortium of federal agency partners: the U.S. Dept. of Health and Human Services (including the National Institute of Child Health and Human Development and the National Institute of Environmental Health Sciences at NIH, and the Centers for Disease Control and Prevention) and the U.S. Environmental Protection Agency.

Dr. Alexander named the following Institutions as the Vanguard Centers for the National Children’s Study:

• University of Utah, Salt Lake City, for the Study location of Salt Lake County, Utah
  
• University of California, Irvine, for the Study location of Orange County, California
  
• University of North Carolina, Chapel Hill, for the Study location of Duplin County, North Carolina
  
• Mount Sinai School of Medicine, New York, for the Study location of Queens County, New York
  
• Children’s Hospital of Philadelphia, Philadelphia, for the Study location of Montgomery County, Pennsylvania.
  
• University of Wisconsin-Madison, Madison, for the Study location of Waukesha County, Wisconsin.

The federal agencies sponsoring the Study are still negotiating to establish two additional Vanguard Centers that will serve counties in other areas.

The Vanguard Centers were selected from a pool of applicants through a competitive process. These centers have successfully demonstrated advanced clinical research and data collection capabilities, with the ability to collect and manage biological and environmental specimens; with community networks for identifying, recruiting, and retaining eligible mothers and infants; and a commitment to the protection and privacy of data.

The Vanguard Centers, which include a variety of universities, hospitals, health departments and other organizations, will work within their communities to recruit participants, collect and process data, and pilot new research methods for incorporation into the full study. The Department of Pediatrics and PCMC have generated support for the study from dozens of agencies in Salt Lake County.

Lorris Betz, M.D., Ph.D., senior vice president for health sciences at the University of Utah, executive dean of the University’s School of Medicine, and CEO of University Health Care, says, “The University of Utah is honored to be among the handful of research institutions selected as a partner in the National Children’s Study. The University’s Department of Pediatrics has a national reputation as a leader in clinical research and the department is uniquely positioned in the community to coordinate the region’s participation in this important study.”

Peter Corroon, mayor of Salt Lake County, said, “I am thrilled that Salt Lake County has been selected as one of the initial study sites for the National Children’s Study. This is great recognition of the quality of pediatric health care available here. Salt Lake County government looks forward to working with the University of Utah Department of Pediatrics and with Primary Children’s Medical Center as they undertake this landmark study.”

Joseph Horton, PCMC CEO, said, “Primary Children’s Medical Center is excited to support the Department of Pediatrics in this landmark project aimed at understanding child health in a holistic way. We further hope the community welcomes the opportunity to participate in this important study, with an understanding that everything learned will benefit our most precious resource – our children – for generations to come.”

Darrell Smith, president of the Salt Lake County Council of Governments and mayor of Draper City, said, “This is a great county to select for a children’s study of this magnitude and significance. We have the enthusiastic support from a broad range of government, health care and community organizations. We have residents who historically have demonstrated their concern about the future of our children. I applaud the Department of Pediatrics for its vision and efforts to include the children of Salt Lake County in this landmark study.”

The planned National Children’s Study resulted from a directive by Congress in 2000 to undertake a national, long-term study of children’s health and their subsequent development in relation to environmental exposures. The NICHD was directed to lead the effort in conjunction with other federal agencies.

The Study has adequate funding to launch the Vanguard Centers. The federal agencies leading it hope to award additional Study Centers to work in a total of 105 sites, subject to the availability of future funding. Future centers would be selected in a competitive process like the one just completed for the Vanguard Centers. The timing of a new competitive process also depends on future funding.

Dr. Alexander added that a coordinating center, WESTAT in Rockville, MD, has been awarded the contract to manage information for the planned National Children’s Study, starting with the Vanguard Centers. WESTAT will collect data, compile and analyze statistics, and ensure that the study proceeds according to design.

Dr. Alexander noted that, in many cases, study researchers would recruit women before they are even pregnant, as well as the women’s partners. Because many pregnancies are unplanned, the researchers will also recruit women who are not considering pregnancy.

The study might eventually lead to preventions or treatments for many common conditions, said Vice Admiral Richard H. Carmona, M.D., M.P.H., FACS, the United States Surgeon General.

“We’re looking to find the root causes of many common diseases and disorders,” Dr. Carmona said. “When we do, we’ll be in a position to prevent them from ever occurring.”

Dr. Carmona added that the study could also shed light on such indoor environmental exposures as secondhand smoke, lead, radon, and asbestos.

“We now know that one in five schools in America has indoor air quality problems, which affect millions of children who don’t even realize it,” Dr. Carmona said. “And that’s where The National Children’s Study comes in. The study could help us map how our environments, habits, and activities affect our children’s health.”

Other speakers at the briefing included representatives of the federal agencies sponsoring the study, as well as representatives of associations concerned with children’s health.