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Prenatal Exposure Effects Psychophysiology Study (PEEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134770
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2010
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
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.

Condition or disease

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction
Study Start Date : July 2008
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Prenatal Cocaine
Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine
Prenatal Nicotine-Alcohol-Marijuana
Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy.
Drug-Free Pregnancy

Subjects did not use any of the following drugs during pregnancy:

cocaine, nicotine, alcohol, marijuana.

Primary Outcome Measures :
  1. Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes [ Time Frame: 2 to 4 weeks of age ]

Biospecimen Retention:   Samples With DNA
Plasma from mothers and buccal cells from infants will be stored for possible DNA analysis of target genes pending additional funding.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women or mothers with their newborn infants.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134770

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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
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Principal Investigator: Karen Grewen, PhD University of North Carolina, Chapel Hill
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Responsible Party: University of North Carolina, Chapel Hill Identifier: NCT01134770    
Other Study ID Numbers: 08-1092
First Posted: June 2, 2010    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of North Carolina, Chapel Hill:
Prenatal Substance Use
Cigarette Smoking
Pregnant women
Smoking Mothers