Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

NCT03670160 | Completed Phase 2 Results FDA Drug

• 1 other identifier: UHS-OB-0001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• Time From Initiation of Adjunctive Therapy Until Hospital Discharge

  Number of days from initiation of adjunctive therapy until hospital discharge

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

Secondary Outcomes (4)

• Length of Stay

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

• Length of Oral Morphine Sulfate Therapy

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

• Number of Patients Requiring Triple Therapy

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

• Readmission Rate

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

Study Arms (2)

Phenobarbital

ACTIVE COMPARATOR

Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.

Drug: Phenobarbital

Clonidine

ACTIVE COMPARATOR

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.

Drug: Clonidine

Interventions

Phenobarbital DRUG

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.

Phenobarbital

Clonidine DRUG

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.

Clonidine

Eligibility Criteria

• Age: 35 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants greater than or equal to 35 weeks gestation age
• Admitted to the neonatal intensive care unit
• Failed monotherapy with morphine sulfate therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee Medical Center: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Phenobarbital; Clonidine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles

Results Point of Contact

• Title: Janet Parkey, Director - Research Compliance
• Organization: University of Tennessee Medical Center

jparkey@utmck.edu

865-305-6194

Study Officials

• Carrie Brusseau, PharmD

  University of Tennessee Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 13, 2018
• Study Start: October 1, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: November 10, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-11

Locations

US (1)