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Prenatal Exposure Effects Psychophysiology Study

Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01134770
Acronym
PEEPS
Enrollment
150
Registered
2010-06-02
Start date
2008-07-01
Completion date
2027-01-01
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Prenatal Substance Use, Cocaine, Cigarette Smoking, Mothers, Pregnant women, Smoking Mothers

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.

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.

Interventions

None listed

Sponsors

University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes2 to 4 weeks of age

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKaren Grewen, PhD

University of North Carolina, Chapel Hill

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026