Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Boston Birth Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease
Preterm Birth Birthweight Pregnancy Complications Pediaric Health Problems

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 24000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Years
Official Title: Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study
Actual Study Start Date : October 1998
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025



Primary Outcome Measures :
  1. preterm birth [ Time Frame: at birth ]
    preterm birth is defined as gestational age less than 37 weeks

  2. birthweight [ Time Frame: at birth ]
    low birthweight is defined as birthweight less than 2500g.

  3. pregnancy complications [ Time Frame: at delivery ]
    multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders during pregnancy

  4. 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

  5. child hypertension [ Time Frame: from 3 years to 21 years ]
    to understand the early life origin and risk factors of child's blood pressure

  6. 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

  7. 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


Biospecimen Retention:   Samples With DNA
Plasma, red blood cell, placenta, urine, DNA, RNA, Swab, Stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
low income, urban, minorities
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228875


Contacts
Layout table for location contacts
Contact: Xiaobin Wang, MD, ScD 410-9555824 xwang82@jhu.edu

Locations
Layout table for location information
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Colleen Pearson, BA    617-414-5133    Colleen.pearson@bmc.org   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Boston University
Investigators
Layout table for investigator information
Principal Investigator: Xiaobin Wang, MD, ScD Johns Hopkins Bloomberg School of Public Health
Additional Information:

Layout table for additonal information
Responsible Party: Xiaobin Wang, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03228875    
Other Study ID Numbers: Boston Birth Cohort
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaobin Wang, Johns Hopkins Bloomberg School of Public Health:
pregnancy outcomes, birth outcomes, pediatric diseases
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Pregnancy Complications
Birth Weight
Obstetric Labor, Premature
Obstetric Labor Complications
Body Weight