Phase 2
N=25
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03670160 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Time From Initiation of Adjunctive Therapy Until Hospital Discharge — 20; 33.8 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Phenobarbital (Drug); Clonidine (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Tennessee Medical Center
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Initiation of Adjunctive Therapy Until Hospital Discharge |
20; 33.8 | — |
| SECONDARY Length of Stay |
31; 41.78 | — |
| SECONDARY Length of Oral Morphine Sulfate Therapy |
25.45; 34.36 | — |
| SECONDARY Number of Patients Requiring Triple Therapy |
4; 10 | — |
| SECONDARY Readmission Rate |
0; 0 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03670160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.