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.|
|ClinicalTrials.gov Identifier: NCT01134770|
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2010
Last Update Posted : October 5, 2020
|Condition or disease|
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):
- nicotine (cigarettes)
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:
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine
Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy.
Subjects did not use any of the following drugs during pregnancy:
cocaine, nicotine, alcohol, marijuana.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01134770
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Karen Grewen, PhD||University of North Carolina, Chapel Hill|