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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01134770
Study type Observational
Source University of North Carolina, Chapel Hill
Contact
Status Enrolling by invitation
Phase
Start date July 2008
Completion date August 2024

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