CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Phenobarbital +1 moredrug
Likely dose
Phenobarbital 20 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03670160
NCT03670160Phase 2Completed
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Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

University of Tennessee Medical Center·interventional·Posted Sep 13, 2018·Updated Nov 10, 2021

In Brief

A Phase 2 clinical trial evaluating Phenobarbital and Clonidine for Neonatal Abstinence Syndrome. Completed, enrolled 25 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Abstinence Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedSep 13, 2018
Enrollment StartOct 1, 2018
Primary CompletionMay 31, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.8 years ago

Interventions

Phenobarbitaldrug

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.

Clonidinedrug

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.