Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01804075 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Morphine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Eastern Maine Medical Center
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of Treatment With Opioid Medication |
13.9; 22.9 | — |
| SECONDARY Second Drug for Withdrawal |
5; 9 | 0.6 |
Summary
Eligibility Criteria
Inclusion Criteria
i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8 hour time period, AND
ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria, AND
iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND
iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.
Exclusion Criteria
i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.
ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,
iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.
iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course
v. Mother consistently taking prescribed benzodiazepine at the time of delivery
Data sourced from ClinicalTrials.gov (NCT01804075). 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.