At a glance
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Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects
In Brief
A Phase 2 clinical trial evaluating fetal monitoring and Buprenorphine Naloxone for Maternal Opioid Use Disorder and Opioid Exposed Infant. Completed, enrolled 42 participants across 1 site.
Detailed Summary
The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, the investigators will study a sample of 120 opioid dependent pregnant women that will receive buprenorphine-naloxone as part of substance abuse treatment at a comprehensive care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and Neonatal Abstinence Syndrome (NAS) spectrum display will be evaluated at birth, and infant neurodevelopment will be assessed during the first month of life.
Study Details
Timeline
Interventions
Maternal fetal monitoring
Treatment for opioid use disorder