Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

University of Tennessee Medical Center

Status and phase: Completed; Phase 2

Conditions: Neonatal Abstinence Syndrome

Treatments: Drug: Clonidine; Drug: Phenobarbital

Study type: Interventional

Funder types: Other

Identifiers

NCT03670160

UHS-OB-0001

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 35+ weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Phenobarbital

Active Comparator group

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.

Treatment:

Drug: Phenobarbital

Clonidine

Active Comparator group

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.

Treatment:

Drug: Clonidine