NCT03670160

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University of Tennessee Medical Center · Academic / Other
• Sex: All
• Age: 35 Weeks
• Healthy volunteers: Not accepted

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).

Conditions

• Neonatal Abstinence Syndrome

Interventions

Type	Name	Description
DRUG	Phenobarbital	Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.
DRUG	Clonidine	Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2018-09-13
• Last updated: 2021-11-10
• Results posted: 2021-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study