Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal (NCT01804075) | Clinical Trial Compass
CompletedPhase 4
Comparison Between Methadone and Morphine for Neonatal Opiate Withdrawal
31 participantsStarted 2011-01
Plain-language 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.
Who can participate
Age range2 Hours – 28 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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
What they're measuring
1
Days of Treatment With Opioid Medication
Timeframe: From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months