Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

October 31, 2017

Study Completion Date

October 31, 2017

Conditions
Neonatal Abstinence SyndromeNeonatal Withdrawal Syndrome
Interventions
DRUG

Buprenorphine

"The injectable formulation of buprenorphine (Buprenex; Reckitt Benckiser) will be prepared to a final concentration of 0.075 mg/mL in 100% ethanol and simple syrup USP to create a sublingual preparation.~Infants initial dose: 15.9 µg/kg per day in 3 divided doses with escalation/weaning based upon standardized scoring of NAS symptoms, using standardized Finnegan scoring Maximum dosage: 60 µg/kg per day Duration: Infants will receive buprenorphine until they are successfully weaned off of opioids and no longer show withdrawal symptoms, evidenced by low Finnegan scores. Mean use in other investigations was 24 days."

DRUG

Morphine Sulfate

Oral Morphine Sulfate Dosage: Morphine Sulfate Oral Solution 100mg/5mL Initially dosed at 0.4mg/kg per day in six daily doses Duration of medication administration dependent upon infant symptoms of neonatal withdrawal, with mean duration of use at Banner Good Samaritan Hospital currently averaging 25 days.

Trial Locations (1)

85006

Banner - University Medical Center Phoenix, Phoenix

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pediatrix

OTHER

NCT01708707 - Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS) | Biotech Hunter | Biotech Hunter