Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

University of Tennessee Medical Center25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neonatal Abstinence Syndrome

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.

Eligibility

Sex: ALLMin age: 35 Weeks

Medical Language ↔ Plain English

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

Locations (1)

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Time From Initiation of Adjunctive Therapy Until Hospital Discharge

Number of days from initiation of adjunctive therapy until hospital discharge

Time frame: From date of randomization until hospital discharge, up to 4 months

Secondary Outcomes

Length of Stay

Number of days of hospital admission

Time frame: From date of randomization until hospital discharge, up to 4 months

Length of Oral Morphine Sulfate Therapy

Number of days of oral morphine sulfate therapy

Time frame: From date of randomization until hospital discharge, up to 4 months

Number of Patients Requiring Triple Therapy

Number of patients requiring a third agent to control withdrawal symptoms

Time frame: From date of randomization until hospital discharge, up to 4 months

Readmission Rate

Number of patients readmitted to the hospital within 30 days of hospital discharge or discontinuation of phenobarbital.

Time frame: From date of randomization until 30 days after hospital discharge or discontinuation of phenobarbital, up to 6 months

Data from ClinicalTrials.gov

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