Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence syndrome (NAS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tennessee Medical Center
• Treatments: Clonidine; Phenobarbital

Criteria

Inclusion Criteria:

• Infants greater than or equal to 35 weeks gestation age

• Admitted to the neonatal intensive care unit

• Failed monotherapy with morphine sulfate therapy

Exclusion Criteria:

• Neonatal abstinence syndrome due to iatrogenic causes

• Unable to take oral medications at any point during their treatment

• Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment