Prenatal Exposure Effects Psychophysiology Study (PEEPS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01134770
First received: May 28, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

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.


Estimated Enrollment: 150
Study Start Date: July 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women or mothers with their newborn infants.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134770

Locations
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
Investigators
Principal Investigator: Karen Grewen, PhD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01134770     History of Changes
Other Study ID Numbers: 08-1092
Study First Received: May 28, 2010
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Prenatal Substance Use
Cocaine
Cigarette Smoking
Mothers
Pregnant women
Smoking Mothers

Additional relevant MeSH terms:
Cocaine
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014