Clinical trial NCT03228875: Boston Birth Cohort Study
Official title: Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal Health
Child Health
Pregnancy Complications
Birth Outcome, Adverse
Keywords: Boston Birth Cohort
Early life origins of pediatric and adult disease
Gene environment interaction
Health across life course and generations
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-07-25
Enrollment: 24000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US, predominantly urban, BIPOC (Black, Indigenous, and people of color).

Brief summary: Early life exposures may lead to adverse effects on health in later life. The Boston birth Cohort study is designed to study a broad array of early life factors and their effects on maternal and child health outcomes.

Detailed description: Any woman admitted to the Labor and Delivery floor at the Boston Medical Center (BMC) who delivers a singleton live infant and meets our case (gestational age \<37 weeks or birthweight \<2,500 grams) or control (full term birth with birthweight \>2,500 grams) criteria will be eligible.

Postnatal follow-up of enrolled mother-child pair is conducted from birth to age 21 years.

The Boston Birth Cohort has high-quality biospecimen collection, and comprehensive epidemiological, clinical, and environmental exposure data via standardized questionnaire interview, measurements, and review of the electronic medical records.

Eligibility criteria: Inclusion Criteria:

* Mothers who deliver singleton live births at Boston Medical Center are eligible for the study.

Exclusion Criteria:

* pregnancies that are a result of in vitro fertilization or that involve multiple gestations, fetal chromosomal abnormalities or major birth defects.

Primary outcomes:
measure: Pregnancy complications
timeFrame: At birth
measure: Birth outcomes - preterm birth
timeFrame: At birth
measure: Birth outcomes - birthweight
timeFrame: At birth
measure: Child health outcomes
timeFrame: From birth to 21 years
measure: Maternal health outcomes
timeFrame: After delivery to 21 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Xiaobin Wang, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McArthur KL, Zhang M, Hong X, Wang G, Buckley JP, Wang X, Mueller NT. Trimethylamine N-Oxide and Its Precursors Are Associated with Gestational Diabetes Mellitus and Pre-Eclampsia in the Boston Birth Cohort. Curr Dev Nutr. 2022 Jun 21;6(7):nzac108. doi: 10.1093/cdn/nzac108. eCollection 2022 Jul.
citation: Huang W, Igusa T, Wang G, Buckley JP, Hong X, Bind E, Steffens A, Mukherjee J, Haltmeier D, Ji Y, Xu R, Hou W, Tina Fan Z, Wang X. In-utero co-exposure to toxic metals and micronutrients on childhood risk of overweight or obesity: new insight on micronutrients counteracting toxic metals. Int J Obes (Lond). 2022 Aug;46(8):1435-1445. doi: 10.1038/s41366-022-01127-x. Epub 2022 May 19.
citation: Lee ASE, Ji Y, Raghavan R, Wang G, Hong X, Pearson C, Mirolli G, Bind E, Steffens A, Mukherjee J, Haltmeier D, Fan ZT, Wang X. Maternal prenatal selenium levels and child risk of neurodevelopmental disorders: A prospective birth cohort study. Autism Res. 2021 Dec;14(12):2533-2543. doi: 10.1002/aur.2617. Epub 2021 Sep 24.
citation: Olapeju B, Hong X, Wang G, Summers A, Burd I, Cheng TL, Wang X. Birth outcomes across the spectrum of maternal age: dissecting aging effect versus confounding by social and medical determinants. BMC Pregnancy Childbirth. 2021 Sep 1;21(1):594. doi: 10.1186/s12884-021-04077-w.
citation: Olapeju B, Ahmed S, Hong X, Wang G, Summers A, Cheng TL, Burd I, Wang X. Maternal Hypertensive Disorders in Pregnancy and Postpartum Plasma B Vitamin and Homocysteine Profiles in a High-Risk Multiethnic U.S., Population. J Womens Health (Larchmt). 2020 Dec;29(12):1520-1529. doi: 10.1089/jwh.2020.8420. Epub 2020 Nov 16.