Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670160
• Other study ID #: UHS-OB-0001
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: November 2021
• Source: University of Tennessee Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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