Phase 4
N=40
Treatment of Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01723722 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Length of Treatment With Opioid Medication — 19.1; 17.7 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Diluted Deodorized Tincture of Opium (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Eastern Maine Medical Center
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Treatment With Opioid Medication |
19.1; 17.7 | — |
Summary
This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.
Eligibility Criteria
Inclusion Criteria
- Evidence of opioid withdrawal clinically as defined by 2 NAS scores >8 or 1 NAS score >12 over a 4 to 8 hour time period, AND
- Gestation >=35 weeks at entry defined by best obstetrical and physical exam criteria, AND
- Medically stable condition, other than in opioid withdrawal, in the opinion of the attending neonatologist, AND EITHER,
- Meconium or urine drug screen positive for opioids on mother or newborn, OR
- Known maternal prescription of opioids for chronic pain management during at least the last trimester of pregnancy, OR
- Known maternal prescription of opioids for treatment of addiction, OR
- Suspected or admitted abuse with opioid drugs
- Infants of mothers with a medical or psychiatric diagnosis will not be excluded, unless the maternal diagnosis precludes informed consent
Exclusion Criteria
- Gestation <35 weeks at entry defined by best obstetrical and physical exam criteria.
- Hypoglycemia, hypomagnesaemia, or hypocalcaemia until corrected.
- Serious medical illness such as sepsis, pneumonia, hyperthyroidism, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.
- Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course.
Data sourced from ClinicalTrials.gov (NCT01723722). 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.