Treatment of Neonatal Abstinence Syndrome

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Maine Medical Center
• Treatments: Methadone; Opium; Phenobarbital

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.