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Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Primary Purpose

Neonatal Abstinence Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Phenobarbital
Clonidine
Sponsored by
University of Tennessee Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Abstinence Syndrome

Eligibility Criteria

35 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Tennessee Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phenobarbital

Clonidine

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Time From Initiation of Adjunctive Therapy Until Hospital Discharge
Number of days from initiation of adjunctive therapy until hospital discharge

Secondary Outcome Measures

Length of Stay
Number of days of hospital admission
Length of Oral Morphine Sulfate Therapy
Number of days of oral morphine sulfate therapy
Number of Patients Requiring Triple Therapy
Number of patients requiring a third agent to control withdrawal symptoms
Readmission Rate
Number of patients readmitted to the hospital within 30 days of hospital discharge or discontinuation of phenobarbital.

Full Information

First Posted
September 5, 2018
Last Updated
November 9, 2021
Sponsor
University of Tennessee Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03670160
Brief Title
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Official Title
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Abstinence Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenobarbital
Arm Type
Active Comparator
Arm Description
Phenobarbital loading dose 20mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital continued throughout the infants hospitalization.
Arm Title
Clonidine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Phenobarbital
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time From Initiation of Adjunctive Therapy Until Hospital Discharge
Description
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 Outcome Measure Information:
Title
Length of Stay
Description
Number of days of hospital admission
Time Frame
From date of randomization until hospital discharge, up to 4 months
Title
Length of Oral Morphine Sulfate Therapy
Description
Number of days of oral morphine sulfate therapy
Time Frame
From date of randomization until hospital discharge, up to 4 months
Title
Number of Patients Requiring Triple Therapy
Description
Number of patients requiring a third agent to control withdrawal symptoms
Time Frame
From date of randomization until hospital discharge, up to 4 months
Title
Readmission Rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie Brusseau, PharmD
Organizational Affiliation
University of Tennessee Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

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Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

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