Prenatal Exposure Effects Psychophysiology Study

Pregnancy Clinical Trial

— PEEPS  

Official title:

Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01134770
• Other study ID #: 08-1092
• Status: Enrolling by invitation
• Start date: July 2008
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes		2 to 4 weeks of age