Major children's study enrolling participants

The nation's largest study of children's health is under way after nearly a decade of planning, with several research sites around the country enrolling participants and beginning to gather data.

The National Children's Study aims to collect information on the many health and environmental factors affecting 100,000 children in 105 U.S. counties from before birth through age 21. Physicians nationwide are involved in every aspect of the study. They are helping to enroll participants, caring for patients, collecting data and conducting research.

"The goals of the study are to understand human development and health across a continuum -- a continuum of time and a continuum of conditions," said Steven Hirschfeld, MD, PhD, acting director of the National Children's Study and associate director for clinical research at the National Institute of Child Health & Human Development.

Thirty-seven sites are active and participating in the study's pilot phase to determine the best way to recruit women who are pregnant or expecting to become pregnant. The main study is expected to begin in early 2012, he said.

"It's a really important study," said Charlotte Hobbs, MD, PhD, the study's principal investigator for Benton County, Ark., and pediatrics professor at the University of Arkansas for Medical Sciences and Arkansas Children's Hospital in Little Rock. "It will give us insights into children's health and the causes of children's illness, factors that help protect our children's health and the factors that may be harmful."

Researchers compare it to long-running studies on adult health, such as the Nurses' Health Study that has been ongoing since 1976 and the Framingham Heart Study that began in 1948.

"Sixty years later, we are still learning very valuable information" from the Framingham study, Dr. Hobbs said. "We don't have anything like that for children."

Within the next decade, the children's study is expected to begin providing insights into the causes and development of a variety of conditions, including asthma, autism, attention-deficit/hyperactivity disorder, obesity and childhood cancer, said Philip J. Landrigan, MD, the study's principal investigator for Queens, N.Y.

Testing recruitment

The National Children's Study was launched as the result of a federal task force appointed in the late 1990s to study the impact of environmental factors on children's health. Task force members quickly discovered there was a dearth of data on the subject, Dr. Hirschfeld said. So the federal government recommended conducting the national multiyear study as part of the Children's Health Act of 2000.

Queens was among the first seven sites to begin recruiting in early 2009, with researchers going door to door. "What we learned in that first year and a half was that you have to knock on 40 to 50 doors to identify a pregnant woman," said Dr. Landrigan, professor of pediatrics and chair of preventive medicine at Mount Sinai Medical Center in New York.

Furthermore, investigators often had to return to a home seven or eight times to get someone to answer the door. "It was extremely labor intensive," he said.

The second phase of the pilot study began in 2010, when 30 more sites came online to test recruitment methods, including direct mailing, recruiting at hospitals and physician practices, and advertising through various media, including TV and radio.

"The goal with the pilot is that we can frame the activities, frame the costs and make this highly efficient to go into as many locations as quickly as possible and enroll as many people as possible," Dr. Hirschfeld said.

Research moves forward

Westmoreland County in Pennsylvania is part of the study's second pilot phase. Investigators there are enrolling pregnant women to participate on two levels, said Jane Cauley, DrPH, the county's principal investigator and professor of epidemiology at the University of Pittsburgh.

Low-intensity participants are asked to be interviewed when their baby is born and fill out surveys every six months. A much larger amount of data will be collected from high-intensity participants, including environmental samples such as water and dust from their homes and communities.

The University of Pittsburgh has used direct mail, billboards and TV and radio advertisements to recruit 53 women, about evenly split between those who are pregnant and those who are trying to conceive. When the pilot ends in the fall, the goal is to recruit 1,000 babies for the study in Westmoreland County, Cauley said.

Thirty women have been recruited in Benton County, Ark., and 162 women have been recruited in Queens. "It is an unprecedented effort," Cauley said.

When the main study begins, Dr. Hirschfeld estimates it will take four years for all 105 sites to become active. "The study will continue to evolve over time," he said. "It's a very fluid situation."