Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The long term goals of our research are to establish the best pharmacological treatment for NAS and determine how pharmacologic treatment of NAS affects long-term developmental outcomes. The objective of this application is to evaluate the effectiveness of clonidine as a treatment for neonates with NAS, in a randomized clinical trial. Our central hypothesis is that clonidine will effectively treat drug withdrawal manifestations in neonates.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrietta Bada; University of Kentucky
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Adrenergic alpha-2 Receptor Agonists; Central Nervous System Depressants; Clonidine; Molecular Mechanisms of Pharmacological Action; Morphine; Opiate Alkaloids; Peripheral Nervous System Agents

Criteria

Inclusion Criteria:

• Gestational age (GA) > or equal to 35 weeks

• Known prenatal opiate exposure (by mother admitting use, mom with positive opiate screen during pregnancy, or positive neonatal urine and meconium screening)

• No known prenatal cocaine exposure

• No morphine or clonidine dose before enrollment

• Symptomatic with Finnegan scores (FS): 3 consecutive scores greater than or equal to 8, OR 2 consecutive scores greater than or equal to 12, and/or with attending decision to treat for NAS

• Less than or equal to 7 days of age

• Attending physician decides to start pharmacologic treatment and agrees to infant's study participation

Exclusion Criteria:

• Seizures

• Major congenital malformations

• Blood pressure instability

• Major medical condition in addition to NAS

• Parents unable to understand English