<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03228875</url>
  </required_header>
  <id_info>
    <org_study_id>Boston Birth Cohort</org_study_id>
    <nct_id>NCT03228875</nct_id>
  </id_info>
  <brief_title>Boston Birth Cohort Study</brief_title>
  <official_title>Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early life exposures may lead to adverse effects on health in later life. The Boston birth&#xD;
      Cohort study is designed to study a broad array of early life factors and their effects on&#xD;
      maternal and child health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Any woman admitted to the Labor and Delivery floor at the Boston Medical Center (BMC) who&#xD;
      delivers a singleton live infant and meets our case (gestational age &lt;37 weeks or birthweight&#xD;
      &lt;2,500 grams) or control (full term birth with birthweight &gt;2,500 grams) criteria will be&#xD;
      eligible.&#xD;
&#xD;
      Postnatal follow-up of enrolled mother-child pair is conducted from birth to age 21 years.&#xD;
&#xD;
      The Boston Birth Cohort has high-quality biospecimen collection, and comprehensive&#xD;
      epidemiological, clinical, and environmental exposure data via standardized questionnaire&#xD;
      interview, measurements, and review of the electronic medical records.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1998</start_date>
  <completion_date type="Anticipated">December 2028</completion_date>
  <primary_completion_date type="Anticipated">December 2028</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>21 Years</target_duration>
  <primary_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>At birth</time_frame>
    <description>Multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders of pregnancy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Birth outcomes - preterm birth</measure>
    <time_frame>At birth</time_frame>
    <description>Birth outcomes are examined - preterm birth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Birth outcomes - birthweight</measure>
    <time_frame>At birth</time_frame>
    <description>Birth outcomes are examined - birthweight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child health outcomes</measure>
    <time_frame>From birth to 21 years</time_frame>
    <description>Multiple child health outcomes are examined including food allergy, asthma, child's overweight or obesity, blood pressure, and child neuro-developmental outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal health outcomes</measure>
    <time_frame>After delivery to 21 years</time_frame>
    <description>Multiple maternal health outcomes are measured including blood pressure, weight, height, physician diagnosis.</description>
  </primary_outcome>
  <enrollment type="Anticipated">24000</enrollment>
  <condition>Maternal Health</condition>
  <condition>Child Health</condition>
  <condition>Pregnancy Complications</condition>
  <condition>Birth Outcome, Adverse</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma, red blood cell, placenta, urine, DNA, RNA, Swab, Stool&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        US, predominantly urban, BIPOC (Black, Indigenous, and people of color).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers who deliver singleton live births at Boston Medical Center are eligible for&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancies that are a result of in vitro fertilization or that involve multiple&#xD;
             gestations, fetal chromosomal abnormalities or major birth defects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaobin Wang, MD, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaobin Wang, MD, ScD</last_name>
    <phone>410-9555824</phone>
    <email>xwang82@jhu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colleen Pearson, BA</last_name>
      <phone>617-414-5133</phone>
      <email>Colleen.pearson@bmc.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Boston Birth Cohort</keyword>
  <keyword>Early life origins of pediatric and adult disease</keyword>
  <keyword>Gene environment interaction</keyword>
  <keyword>Health across life course and generations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03228875
org study id: Boston Birth Cohort
nct id: NCT03228875
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Pregnancy complications
time frame: At birth
description: Multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders of pregnancy.
measure: Birth outcomes - preterm birth
time frame: At birth
description: Birth outcomes are examined - preterm birth.
measure: Birth outcomes - birthweight
time frame: At birth
description: Birth outcomes are examined - birthweight.
measure: Child health outcomes
time frame: From birth to 21 years
description: Multiple child health outcomes are examined including food allergy, asthma, child's overweight or obesity, blood pressure, and child neuro-developmental outcomes.
measure: Maternal health outcomes
time frame: After delivery to 21 years
description: Multiple maternal health outcomes are measured including blood pressure, weight, height, physician diagnosis.
Plasma, red blood cell, placenta, urine, DNA, RNA, Swab, Stool
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: 21 Years
healthy volunteers: No
last name: Xiaobin Wang, MD, ScD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
last name: Xiaobin Wang, MD, ScD
phone: 410-9555824
email: xwang82@jhu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Pregnancy Complications
sharing ipd: No