Treatment of Neonatal Abstinence Syndrome
Completed · Phase 4
Conditions studied: Neonatal Abstinence Syndrome
In brief
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.
Key facts
- Study ID
- NCT01723722
- Run by
- Eastern Maine Medical Center
- People needed
- 40
- Starts
- 2007-01-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2013-11-27
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Eastern Maine Medical Center — Bangor, Maine, United States
Full record on ClinicalTrials.gov
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