Phase 2
Completed N=25
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Source: ClinicalTrials.gov NCT03670160 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Time From Initiation of Adjunctive Therapy Until Hospital Discharge — 20; 33.8 Days
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).
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 | — |
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. Informational only — not medical advice.