Clinical Trial: Treatment of Neonatal Abstinence Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Neonatal Abstinence Syndrome: Evaluation of Efficacy of Phenobarbital in Combination With Either Methadone or Diluted Deodorized Tincture of Opium as Stabiliz
Brief 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.
Detailed Summary:
a.Procedures: NAS scoring is currently done on infants meeting the inclusion criteria [IDD 29:070]. NAS scores are initially done every 2 hours for 24 hours and then every 4 hours when awake or before feeding for the duration of observation or treatment.
i. NAS scores may indicate more than withdrawal. Conditions such as colic, reflux, or baseline irritability may influence the baseline scores. Decisions made based on the NAS scores should take into account these factors and the baseline for the infant.
b.Emergence of symptom, dosing, and initiation of treatment: Withdrawal is defined as at least 2 NAS scores >8 or 1 NAS score >12. Once withdrawal has emerged, the infant will be given: i. Phenobarbital 20 to 30 mg/kg to load divided in up to 3 doses over 24 hours and maintenance phenobarbital should be started at 2.5 mg/kg/dose administered Q 12h, 12 hours after the loading dose is ended. NAS scoring is continued and if scores remain <8 for a minimum of 5 days after starting phenobarbital, the infant is eligible for discharge.
ii. If after phenobarbital treatment has been started, at least 2 NAS scores >8 or 1 NAS score >12, then a phenobarbital level will be drawn and a mini-load calculated to reach a level of 30 mg/dl. If withdrawal is not controlled or re-emerges after the mini-load dose, the infant will be randomized to one of the two arms of the study - methadone or dDTO.
iii. Twins will be randomized together to the same arm. iv. Randomization will be stratified into mothers on narcotic treatment >3 months and those not in treatment or <3 months. Randomization will be done in blocks of 10 for each stratum.
v. For both drugs, the neonatal preparation
Sponsor: Eastern Maine Medical Center
Current Primary Outcome: Length of Treatment With Opioid Medication [ Time Frame: Up to 12 months ]
Original Primary Outcome: Number of days of treatment with opioid medication for withdrawal [ Time Frame: Number of days between date of start and date of end of opiod medication (average 25 days) ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Eastern Maine Medical Center
Dates:
Date Received: January 27, 2011
Date Started: January 2007
Date Completion:
Last Updated: November 5, 2013
Last Verified: November 2013
