NCT00852904

National Children s Health Study

Completed Last updated 1 June 2020

What this trial tests

trial in Infant in 9,942 participants. Completed in 29 May 2020.

Timeline

25 February 2009

Primary endpoint
12 December 2014

29 May 2020

Quick facts

Lead sponsor	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	9,942
Start date	25 February 2009
Primary completion	12 December 2014
Estimated completion	29 May 2020
Sites	4 locations across United States

Conditions studied

• Infant — all drugs for Infant →
• Child Development — all drugs for Child Development →
• Biological Samples — all drugs for Biological Samples →

Sponsor

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

Who can join

18 and older, any sex, with Infant or Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early experiences and predictors of recruitment success for the National Children's Study.
   Trasande L, Andrews HF, Goranson C, Li W, et al · · 2011 · cited 11× · PMID 21262893 · DOI 10.1542/peds.2010-2334
2. The National Children's Study: Recruitment Outcomes Using the Provider-Based Recruitment Approach.
   Hale DE, Wyatt SB, Buka S, Cherry D, et al · · 2016 · cited 10× · PMID 27251870 · DOI 10.1542/peds.2015-4410e
3. Comparison of Recruitment Strategy Outcomes in the National Children's Study.
   Park CH, Winglee M, Kwan J, Andrews L, et al · · 2017 · cited 9× · PMID 28724571 · DOI 10.1542/peds.2016-2822
4. The National Children's Study: Early Recruitment Outcomes Using the Direct Outreach Approach.
   McGovern PM, Nachreiner NM, Holl JL, Halfon N, et al · · 2016 · cited 8× · PMID 27251869 · DOI 10.1542/peds.2015-4410d
5. The Experience of Direct Outreach Recruitment in the National Children's Study.
   Kaar JL, Markovic N, Amsden LB, Gilliland J, et al · · 2016 · cited 5× · PMID 27251872 · DOI 10.1542/peds.2015-4410g
6. Multilevel Provider-Based Sampling for Recruitment of Pregnant Women and Mother-Newborn Dyads.
   McLaughlin TJ, Aupont O, Kozinetz CA, Hubble D, et al · · 2016 · cited 2× · PMID 27251871 · DOI 10.1542/peds.2015-4410f
7. Influence of Food Security Status and Diet Quality on Maternal Gestational Weight Gain.
   Sparks JR, Myers CA, Phelan S, Newton RL, et al · · 2024 · cited 1× · PMID 38553830 · DOI 10.1111/jmwh.13622
8. The National Children's Study Archive Model: A 3-Tier Framework for Dissemination of Data and Specimens for General Use and Secondary Analysis.
   Gilbertson PK, Forrester S, Andrews L, McCann K, et al · · 2021 · cited 1× · PMID 33748052 · DOI 10.3389/fpubh.2021.526286