Status:
COMPLETED
A Study of Breastfeeding in Buprenorphine Maintained Women
Lead Sponsor:
Johns Hopkins University
Conditions:
Opioid Dependency
Eligibility:
FEMALE
18-41 years
Brief Summary
Goals: The overarching goals for this proposed research are to provide pilot data for a study to inform the FDA regarding the safety of breastfeeding infants of mothers on buprenorphine maintenance an...
Detailed Description
This study recruits participants from a funded trial evaluating fetal neurobehavior and maternal physiology among a population of opioid dependent and buprenorphine maintained pregnant women. Those wo...
Eligibility Criteria
Inclusion
- Age 18-41 years
- Opioid dependent per DSMIVR criteria, buprenorphine maintained, enrolled in parent study.
- Delivery at 37 weeks of gestation or later
- Breast feeding in the first month of life
Exclusion
- Concurrent Axis I diagnosis, or the presence of a serious psychiatric illness that would preclude informed consent
- Major congenital malformation or minor congenital malformation that would impair the infant's ability to feed (i.e. Pierre-Robin syndrome, cleft palate)
- Delivery at an outside institution unaffiliated with this protocol
- Failure to leave specimens as per protocol
- Infant medical complications that impair the ability to feed after delivery (i.e. respiratory concerns such as meconium aspiration, perinatal asphyxia, etc. These will be individually determined on a case-by-case basis)
- Any detected maternal medical condition making lactation inadvisable, i.e. newly diagnosed HIV infection or requirement for medication not compatible with breastfeeding.
- Infants with other medical conditions that would make study participation impossible, i.e. nonviable neonates, neonates with uncertain viability.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01806389
Start Date
February 1 2013
End Date
February 1 2016
Last Update
June 15 2017
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