National Children s Health Study

NCT00852904 | Completed

• 2 other identifiers: 99990908309-CH-N083
• Study Type: observational
• Target: 9,942
• Locations: 1 country
• Sites: 4

Brief Summary

Patterns of illness among children in the United States and other industrially developed nations have changed substantially during the past 100 years. Before and during the first half of the previous century, infectious diseases were the primary threat to children s health. In contrast, the major illnesses and disorders that impair health, growth, and development today are chronic conditions stemming from the complex interaction of environmental exposures and inherent genetic factors. The Children s Health Act of 2000 directed the National Institute of Child Health and Development to conduct a national longitudinal study of environmental influences on children s health in the United States. The act specified that the study extend from the prenatal period to adulthood and investigate the short-term and long-term influences of physical, chemical, biological, and psychosocial environmental exposures on children s health and development, including behavioral, emotional, and educational outcomes in addition to physical health. The National Children s Study (NCS) is an observational longitudinal study that will enroll and follow a nationally representative sample of approximately 100,000 U.S.-born children from before birth through their 21st birthday. The study will screen all households within selected areas of 105 locations (primarily counties). The major types of analysis of NCS data will include longitudinal exposure-outcome analysis, identification of causal pathways, analysis of neighborhood effects, evaluation of temporal effects within longitudinal data analysis of data from case-control data, and analysis of genomic data. Women in their first trimester of pregnancy will be invited to participate in the pre-pregnancy portion of the NCS. Women who are not pregnant but have a high probability of becoming pregnant will be asked to participate in the early pregnancy portion of the NCS. All other eligible women will be asked if the study can contact them periodically to assess their pregnancy status. They also will be asked to contact the NCS should they become pregnant. Women identified as pregnant within 4 years after initial screening will be invited to enroll in the NCS. The following information will be gathered: Mother s data and information

• Questionnaire data interviewed and self-administered (e.g., demographics; current pregnancy history; reproductive history; medical conditions; health behaviors; doctor visits; medicines and supplements; housing characteristics; pesticides, product use; occupation, hobbies; depression, stress; social support; diet; time and activity)
• Physical measures and clinical data (e.g., blood pressure, sonograms, height, weight, body measurements)
• Biologic specimens (e.g., blood, urine, hair, saliva)
• Environmental samples during home visits (e.g., dust, air, water)
• Medical record abstraction Infant s data and information at birth
• Cord blood and tissue samples of the placenta and umbilical cord
• Standardized neurobehavioral exam
• Physical measures and clinical data (e.g., length; weight; circumferences of head, arm, abdomen, thigh)
• Meconium samples
• Medical diagnoses and treatment by report
• Selected Medical record abstraction

Conditions

Infant; Child Development; Biological Samples

Keywords

Childhood Growth and Development; Genetics; Children; Environment; Longitudinal Study; National Children's Study

Outcome Measures

Primary Outcomes (1)

• Assess feasibility, acceptability and cost of: Recruitment, accrual, enrollment and retention strategies; Study logistics and operations; Study visit assessments including newly developed assessmentsfor reliability, reproducibility and stabil...

  Feasibility, acceptability and cost of the elements that will form the Main Study

  During and after pregnancy, throughout infancy and childhood until age 21

Secondary Outcomes (1)

• Evaluation of recruitment, enrollment and retention strategies

  Ongoing

Study Arms (1)

NCS Vanguard cohort

Women of child bearing potential, children born to women enrolled in the study, the children s biological and/or social fathers, and primary caregivers (if other than parent)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women of child bearing potential, their children, the children's biological and/or ocial fathers, and primary caregivers (if other than parent)

You may qualify if:

• Women age 18-49 years of age at the time of enumeration who medically could be pregnant
• Pregnant women at or above the local age of majority
• During the Initial Vanguard Study recruitment period only: pregnant women aged younger than 18, residing in a selected NCS geographic segment at the time of enrollment, who are considered to be emancipated minors per the laws of their jurisdiction or minor pregnant women who obtain parental consent for participation
• Children born to enrolled women
• Biological and social fathers as identified by enrolled women
• Adult guardians who have legal responsibility to authorize needed care for enrolled children
• Adults who are primary caregivers of enrolled children

You may not qualify if:

• Women self-reported to be infertile
• Adults who are unable to understand what is involved in NCS participation and grant informed consent
• Prisoners as defined in 45 CFR 46.303\[c\]

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

NORC at the Univ. of Chicago

Chicago, Illinois, United States

Location

National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, 20892, United States

Location

Westat, Inc.

Rockville, Maryland, 20850, United States

Location

Related Publications (9)

• Hudak ML, Park CH, Annett RD, Hale DE, McGovern PM, McLaughlin TJ, Dole N, Kaar JL, Balsam MJ. The National Children's Study: An Introduction and Historical Overview. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S213-8. doi: 10.1542/peds.2015-4410B.

  PMID: 27251867 BACKGROUND

• Li Q, Kappil MA, Li A, Dassanayake PS, Darrah TH, Friedman AE, Friedman M, Lambertini L, Landrigan P, Stodgell CJ, Xia Y, Nanes JA, Aagaard KM, Schadt EE, Murray JC, Clark EB, Dole N, Culhane J, Swanson J, Varner M, Moye J, Kasten C, Miller RK, Chen J. Exploring the associations between microRNA expression profiles and environmental pollutants in human placenta from the National Children's Study (NCS). Epigenetics. 2015;10(9):793-802. doi: 10.1080/15592294.2015.1066960. Epub 2015 Aug 7.

  PMID: 26252056 BACKGROUND

• Park CH, Winglee M, Kwan J, Andrews L, Hudak ML. Comparison of Recruitment Strategy Outcomes in the National Children's Study. Pediatrics. 2017 Aug;140(2):e20162822. doi: 10.1542/peds.2016-2822.

  PMID: 28724571 BACKGROUND

• Gilbertson PK, Forrester S, Andrews L, McCann K, Rogers L, Park C, Moye J. The National Children's Study Archive Model: A 3-Tier Framework for Dissemination of Data and Specimens for General Use and Secondary Analysis. Front Public Health. 2021 Mar 5;9:526286. doi: 10.3389/fpubh.2021.526286. eCollection 2021.

  PMID: 33748052 DERIVED

• Kaar JL, Markovic N, Amsden LB, Gilliland J, Shorter CF, Peters B, Nachreiner NM, Garel M, Nicholas W, Skarpness B, Drews-Botsch C, Hogue CJ, Dabelea D. The Experience of Direct Outreach Recruitment in the National Children's Study. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S258-64. doi: 10.1542/peds.2015-4410G.

  PMID: 27251872 DERIVED

• McLaughlin TJ, Aupont O, Kozinetz CA, Hubble D, Moore-Simas TA, Davis D, Park C, Brenner R, Sepavich D, Felice M, Caviness C, Downs T, Selwyn BJ, Forman MR. Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S248-57. doi: 10.1542/peds.2015-4410F.

  PMID: 27251871 DERIVED

• Hale DE, Wyatt SB, Buka S, Cherry D, Cislo KK, Dudley DJ, McElfish PA, Norman GS, Reynolds SA, Siega-Riz AM, Wadlinger S, Walker CK, Robbins JM. The National Children's Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S239-47. doi: 10.1542/peds.2015-4410E.

  PMID: 27251870 DERIVED

• McGovern PM, Nachreiner NM, Holl JL, Halfon N, Dabelea D, Caulfield L, Cauley JA, Innocenti MS, Amsden L, Markovic N, Riddles M, Adams S. The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach. Pediatrics. 2016 Jun;137 Suppl 4(Suppl 4):S231-8. doi: 10.1542/peds.2015-4410D.

  PMID: 27251869 DERIVED

• Trasande L, Andrews HF, Goranson C, Li W, Barrow EC, Vanderbeek SB, McCrary B, Allen SB, Gallagher KD, Rundle A, Quinn J, Brenner B. Early experiences and predictors of recruitment success for the National Children's Study. Pediatrics. 2011 Feb;127(2):261-8. doi: 10.1542/peds.2010-2334. Epub 2011 Jan 24.

  PMID: 21262893 DERIVED

Study Officials

• Jack Moye, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: February 27, 2009
• Study Start: February 25, 2009
• Primary Completion: December 12, 2014
• Study Completion: May 29, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

US (4)