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PEEPS: Prenatal Exposure Effects Psychophysiology Study

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT01134770
Collaborator
(none)
150
Enrollment
1
Location
181
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to understand the biology and behavior of early mother-infant attachment, and to investigate how it may be affected by prenatal substance exposures. The investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette smoking affect both mother and baby.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators are looking for pregnant women or mothers with their newborn infants to participate in this study. Eligible women include mothers who have used any of the following drugs at any time during pregnancy (alone or in combination):

    1. cocaine

    2. nicotine (cigarettes)

    3. marijuana

    4. alcohol

    The investigators are also looking for mothers who have not used any drugs during pregnancy.

    Information collected in this research study is strictly confidential, and protection of sensitive information is additionally assured by an NIH Certificate of Confidentiality.

    Participation in this study involves:

    1. One visit at 2-4 weeks postpartum. This visit includes an interview for mother and a 30 minute brain scan (no radiation, no sedation) for baby.

    2. Two visits at 3 months postpartum. Mothers will have blood pressure and heart rate measured while they look at videos about babies, listen to baby sounds, interact with their own baby. Samples of blood, urine and saliva will be taken from mother. Baby will have a developmental assessment, and saliva samples will be taken.

    Payment is $300 or the equivalent in Walmart gift cards for completion of brain imaging, lab visits and 1 day of monitoring mother's blood pressure at home.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction
    Study Start Date :
    Jul 1, 2008
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Prenatal Cocaine

    Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine
    Prenatal Nicotine-Alcohol-Marijuana

    Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy.
    Drug-Free Pregnancy

    Subjects did not use any of the following drugs during pregnancy: cocaine, nicotine, alcohol, marijuana.

    Outcome Measures

    Primary Outcome Measures

    1. Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes [2 to 4 weeks of age]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • During pregnancy, mother has used any of the following:

    • cocaine

    • marijuana and/or alcohol but not cocaine

    • nicotine (smoked cigarettes)

    • no drugs during pregnancy

    • Mother is pregnant or no more than 4 weeks postpartum

    Exclusion Criteria:

    • Mother has cardiovascular disease

    • Delivery before 36 weeks or later than 42 weeks gestation

    • Birth weight less than 5.5 lbs

    • Baby was a multiple birth

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill

    Investigators

    • Principal Investigator: Karen Grewen, PhD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT01134770
    Other Study ID Numbers:
    • 08-1092
    First Posted:
    Jun 2, 2010
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of North Carolina, Chapel Hill
    Prenatal Substance Use
    Cocaine
    Cigarette Smoking
    Mothers
    Pregnant women
    Smoking Mothers

    Study Results

    No Results Posted as of Aug 25, 2022