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 National Children's Study to Select Vanguard Centers and Coordinating Center (December 2004)

Study Plan, Vanguard Centers, and Coordinating Center

Comments about the recently posted Requests for Proposals (RFP) should be directed to Virginia DeSeau at deseauv@mail.nih.gov, or Teneshia Alston for the Coordinating Center at alstont@mail.nih.gov, or Dawn Rabunsky for Vanguard Centers at drabunsk@nichd.nih.gov.

All revisions made to the RFPs will be posted to:
Vanguard Centers:
https://www.fbo.gov/spg/
HHS/NIH/NICHD/Awards/
HHSN275200503396C.html

Coordinating Center:
https://www.fbo.gov/spg/
HHS/NIH/NICHD/RFP-NICHD-2004-12/listing.html


Upcoming Events

National Children's Study Clinical Event Information Workshop

Date and Location: TBD

Since the September E-Update was published, the following meetings were planned and held:

National Children's Study Coordinating Center Pre-Proposal Conference

November 30, 2004,
JW Marriott Pennsylvania Avenue, Washington, DC

National Children's Study Vanguard Sites Pre-Proposal Conference

December 1, 2004,
JW Marriott Pennsylvania Avenue, Washington, DC

Time-Use Workshop

December 9–10, 2004,
Crowne Plaza Crystal City, Arlington, VA


Good To Know

Possible Link Between Maternal Diet and Childhood Leukemia

Researchers recently established a link between the nutritional composition of the in utero environment and the risk of acute lymphoblastic leukemia (ALL). 1 Though most causal factors for ALL are unknown, findings from the Northern California Childhood Leukemia Study, conducted by scientists at the University of California at Berkeley and the Yale University School of Medicine, suggest that genetic events responsible for the development of ALL can occur in utero.

In their study of risk factors for childhood leukemia, including maternal diet, researchers found that mothers' recall of a pre-pregnancy diet high in antioxidants, contained in foods such as carrots, string beans, peas, beef, beans, and cantaloupe, correlated with a lower incidence of ALL in the child from that pregnancy. The study further showed that antioxidants, such as carotenoids and glutathione, present in fruits, vegetables, and protein sources, may reduce the risk of ALL by protecting against oxidative damage to DNA, known to be an early genetic event involved in cancer development.

The National Children's Study is pursuing a strategy to enable the investigation of such infrequent outcomes that would otherwise be too infrequent for the National Children's Study sample size of 100,000 children. In concert with investigators for other large childhood cohort studies around the world, planning is under way to form a consortium of cohorts large enough (totaling approximately 500,000 children) to measure possible effects of environmental influences on childhood cancer and other similarly infrequent outcomes. This cohort consortium could potentially contribute significant data about the role of diet in the risk of childhood cancer, collecting information on diet and dietary changes as they occur. In this manner, the National Children's Study will be working to solve some of the most difficult health problems facing children today.

1Jensen CD, Block G, Buffler P, Ma X, Selvin S, Month S. Maternal dietary risk factors in childhood acute lymphoblastic leukemia (United States). Cancer Causes Control 2004; 15(6):559-70.




Feature

National Children's Study to Select Vanguard Centers and Coordinating Center

The National Children's Study continues to lay the groundwork for Study implementation, the first step of which involves a review of proposals from organizations and institutions applying to become one of the Vanguard Centers or the Coordinating Center for the Study. The Study's $12 million fiscal year 2005 (FY2005) budget will go toward the funding of at least three Vanguard Centers to manage Vanguard Study sites, and one Coordinating Center to provide research support, clinical coordination, and data management and analysis.

Initial Vanguard Center activities will include helping Study planners finalize the Study protocol, developing a plan for community engagement, hiring staff, and preparing for participants to enroll and engage in Study examinations. Once selected, the Coordinating Center will assist the National Children's Study in continued planning and implementation, such as the development of scientific background papers and the design and evaluation of preliminary studies.

Additional Study Centers will be needed in the remaining Study locations and the Vanguard Centers will begin initial enrollment, data collection, and fine-tuning of the Study plan to ensure effectiveness for the duration of the Study.

To support the Study as it moves into implementation, the U.S. Environmental Protection Agency (EPA), one of the Study's leading federal partners, will lend its technical and scientific expertise in the area of information technology, data modeling, and information management. Various roles regarding the state of the art EPA National Computer Center and the IT staff are being discussed.

The EPA, through its Science to Achieve Results (STAR) grants program, has recently posted a Request for Applications (RFA) for research to investigate early indicators of environmentally induced disease. This RFA seeks proposals from academic and not-for-profit institutions to develop methods and tools that will be useful in longitudinal epidemiology studies—including the National Children's Study—as early indicators or predictors of environmentally induced disease. This RFA can be found at:
http://epa.gov/ncer/rfa/2004/2004early_indicators.html.

Requests for Proposals (RFP) for the Coordinating Center will be received until January 21, 2005. RFPs for the Vanguard Centers will be received until February 16, 2005. Revisions to the RFPs are available at:

Vanguard Centers:
https://www.fbo.gov/spg/HHS/NIH/NICHD/Awards/
HHSN275200503396C.html

Coordinating Center:
https://www.fbo.gov/spg/HHS/NIH/NICHD/RFP-NICHD-2004-12/
listing.html

Lewis Berman and Lester R. Curtin Join the National Children's Study Program Office

Lewis Berman, MS, recently joined the National Children's Study Program Office as a computer scientist consulting on design and architecture of the information management system that will be used to collect all data for the National Children's Study. Mr. Berman currently serves as special assistant to the director of the National Health and Nutrition Examination Survey (NHANES) for research, informatics, and Community Health and Nutrition Examination Surveys (HANES) in the National Center for Health Statistics (NCHS), at the Centers for Disease Control and Prevention (CDC). He is also co-project director for the New York City HANES for NCHS. Prior to these roles, Mr. Berman was chief of the Informatics Branch of the Division of Health and Nutrition Examination Surveys for seven years.

Mr. Berman will organize technical and scientific aspects of the National Children's Study into the information management system used to gather clinical data from the disparate collection sites, including clinics at Study sites, participants' households, and call centers.

Lester R. Curtin, PhD, has joined the National Children's Study as a biostatistical consultant and is working to determine the sampling method for selecting Study participants. Currently a mathematical statistician in the Division of Health and Nutrition Examination Statistics within the NCHS at CDC, Dr. Curtin is a design analyst for NHANES. He previously served as the director of the Division of Vital Statistics and also as chief of the Statistical Method Staff within NCHS. Dr. Curtin became involved in the National Children's Study because it is a highly complex and challenging exercise in the work of statistical data analysis, and at the same time very rewarding because of the impact it will have on children's health.

Recently, Dr. Curtin prepared materials for the Study Design Working Group which helped guide the working group in its recommendation of a probability sample versus a non-probability sample for the Study. Dr. Curtin is now preparing the multiple stages of the sampling design. Dr. Curtin's design analysis will provide a process for how people are chosen to be invited into the Study, with a goal of an unbiased selection process.

National Children's Study in the News

The National Children's Study continues to gain media attention. Recent news coverage has included:

Associated Press — November 16, 2004
"Nation's Largest Study Tracks Kids' Health"

Reuters — November 17, 2004
"U.S. Launches Giant Study on Children"

HealthDay — December 16, 2004
"U.S. to Launch Massive Study Into Children's Health"

Science — December 10, 2004
"NIH Launches Controversial Long-Term Study of 100,000 U.S. Kids"

Pittsburgh Post-Gazette — November 17, 2004
"U.S. Launches Study of Children's Health"

Deseret Morning News — November 17, 2004
"County May Join Study of Children"

Ventura County Star — December 7, 2004
"County Included in Health Research, Study to Track Kids Pre-Birth to Age 21"

Nature — November 24, 2004
"Huge Study of Children Aims to Get the Dirt on Development"

Waukesha Freeman — December 2, 2004
"County Eyed for National Study"

The following television stations aired stories about the National Children's Study: NBC Today Show; CNN Headline News; WPIX in New York; KABC in Los Angeles; KRIV and KTRK in Houston; and KDKA and WPXI in Pittsburgh

The following radio stations aired stories about the National Children's Study: CNN Radio Network and WNPV-AM in Lansdale, PA

AAP News — September 2004
"Study to Examine How Environment Influences Health and Development"

Environmental Health Perspectives — October 2004
"The National Children's Study: A Critical National Investment"

Comments or Questions?

E-mail us.
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


  6/1/2008
  7/27/2005