Prenatal Exposure Effects Psychophysiology Study

• Conditions: Pregnancy

• Registration Number: NCT01134770
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-06-02
• Status Verified: 2023-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes	2 to 4 weeks of age

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States