Status:
COMPLETED
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
Lead Sponsor:
Eastern Maine Medical Center
Conditions:
Neonatal Abstinence Syndrome
Eligibility:
All Genders
2-28 years
Phase:
PHASE4
Brief Summary
Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.
Detailed Description
The purpose is to compare treatment of NAS with two different initial medications with primary outcome of (1) reducing the duration of opiate medication treatment and (2) reducing the number of infant...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01804075
Start Date
January 1 2011
End Date
October 1 2012
Last Update
September 28 2017
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