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Boston Birth Cohort Study

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ClinicalTrials.gov Identifier: NCT03228875
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Boston University
Information provided by (Responsible Party):
Xiaobin Wang, Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date July 20, 2017
First Posted Date July 25, 2017
Last Update Posted Date February 13, 2020
Actual Study Start Date October 1998
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 10, 2020)
  • preterm birth [ Time Frame: at birth ]
    preterm birth is defined as gestational age less than 37 weeks
  • birthweight [ Time Frame: at birth ]
    low birthweight is defined as birthweight less than 2500g.
  • pregnancy complications [ Time Frame: at delivery ]
    multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders during pregnancy
  • child overweight or obesity [ Time Frame: from birth to 21 years ]
    multiple child health outcomes are examined including food allergy, asthma, to understand the early life origin and risk factors of child's overweight or obesity
  • child hypertension [ Time Frame: from 3 years to 21 years ]
    to understand the early life origin and risk factors of child's blood pressure
  • Child neuro-developmental outcomes [ Time Frame: from birth to 21 years ]
    To investigate the early life origin and risk factors of child's neuro-developmental outcomes, including ASD, ADHD
  • food allergy, asthma [ Time Frame: from birth to 21 years ]
    To investigate the early life origin and risk factors of child's food allergy, asthma
Original Primary Outcome Measures
 (submitted: July 21, 2017)
  • preterm birth [ Time Frame: at birth ]
    preterm birth is defined as gestational age less than 37 weeks
  • birthweight [ Time Frame: at birth ]
    low birthweight is particularly focused on.
  • pregnancy complications [ Time Frame: at delivery ]
    multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders during pregnancy
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Boston Birth Cohort Study
Official Title Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
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 pregnancy, infancy, 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 children 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 21 Years
Biospecimen Retention:   Samples With DNA
Description:
Plasma, red blood cell, placenta, urine, DNA, RNA, Swab, Stool
Sampling Method Non-Probability Sample
Study Population low income, urban, minorities
Condition
  • Preterm Birth
  • Birthweight
  • Pregnancy Complications
  • Pediaric Health Problems
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 10, 2020)
24000
Original Estimated Enrollment
 (submitted: July 21, 2017)
12000
Estimated Study Completion Date December 2025
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Mothers who deliver singleton live births 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.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 21 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xiaobin Wang, MD, ScD 410-9555824 xwang82@jhu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03228875
Other Study ID Numbers Boston Birth Cohort
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xiaobin Wang, Johns Hopkins Bloomberg School of Public Health
Study Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborators Boston University
Investigators
Principal Investigator: Xiaobin Wang, MD, ScD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date February 2020