Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Phase 2

Completed

• Conditions: Neonatal Abstinence Syndrome
• Interventions: Drug: Phenobarbital; Drug: Clonidine

• Registration Number: NCT03670160
• Lead Sponsor: University of Tennessee Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Study Start: 2018-10-01
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Results First Submitted: 2021-08-02
• Results First Submitted QC: 2021-10-11
• Status Verified: 2021-11
• Results First Posted: 2021-11-09
• Last Update Submitted: 2021-11-09
• Last Update Posted: 2021-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenobarbital	Phenobarbital	Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.
Clonidine	Clonidine	Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.

Primary Outcome Measures

Name	Time	Method
Time From Initiation of Adjunctive Therapy Until Hospital Discharge	From date of randomization until hospital discharge, up to 4 months	Number of days from initiation of adjunctive therapy until hospital discharge

Secondary Outcome Measures

Name	Time	Method
Readmission Rate	From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months	Number of patients readmitted to the hospital within 30 days of hospital discharge or discontinuation of phenobarbital.
Length of Stay	From date of randomization until hospital discharge, up to 4 months	Number of days of hospital admission
Length of Oral Morphine Sulfate Therapy	From date of randomization until hospital discharge, up to 4 months	Number of days of oral morphine sulfate therapy
Number of Patients Requiring Triple Therapy	From date of randomization until hospital discharge, up to 4 months	Number of patients requiring a third agent to control withdrawal symptoms

Trial Locations

Locations (1)

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States