Prenatal Exposure Effects Psychophysiology Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction
Overview
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.
Primary outcome measures
- Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes [Time frame: 2 to 4 weeks of age]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT01134770 · 08-1092