Clinical trial NCT01134770: Prenatal Exposure Effects Psychophysiology Study
Official title: Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pregnancy
Keywords: Prenatal Substance Use
Cocaine
Cigarette Smoking
Mothers
Pregnant women
Smoking Mothers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2010-06-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women or mothers with their newborn infants.

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.

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 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

Primary outcomes:
measure: Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes
timeFrame: 2 to 4 weeks of age
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Karen Grewen, PhD
role: PRINCIPAL_INVESTIGATOR
References: