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Completed

NCT Number: NCT03670160

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

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).

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Key information

Conditions

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

Age range

35 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Time From Initiation of Adjunctive Therapy Until Hospital Discharge

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

    Number of days from initiation of adjunctive therapy until hospital discharge

Secondary outcomes

  1. Length of Stay

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

    Number of days of hospital admission

  2. Length of Oral Morphine Sulfate Therapy

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

    Number of days of oral morphine sulfate therapy

  3. Number of Patients Requiring Triple Therapy

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

    Number of patients requiring a third agent to control withdrawal symptoms

  4. Readmission Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Tennessee Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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