Comparison of Buprenorphine to Morphine in Treatment of Neonatal Abstinence Syndrome (NAS)
The purpose of the study is to determine whether buprenorphine is a beneficial, safe, cost effective treatment alternative to morphine sulfate in the treatment of Neonatal Abstinence Syndrome (NAS).
Neonatal Abstinence Syndrome
Neonatal Withdrawal Syndrome
Drug: Morphine Sulfate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)|
- Hospital length of stay [ Time Frame: Up to hospital discharge, an anticipated average of 4 weeks ] [ Designated as safety issue: No ]Number of days of hospital admission
- Number of adverse or serious adverse events [ Time Frame: Up to hospital discharge, with length of stay currently averaging approximately 4 weeks ] [ Designated as safety issue: Yes ]
- Cost efficiency of buprenorphine [ Time Frame: At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks ] [ Designated as safety issue: No ]Cost of buprenorphine as a product of number of days of administration
- Withdrawal symptoms [ Time Frame: Up to hospital discharge, usually occuring on average 4 weeks ] [ Designated as safety issue: No ]Finnegan methodology to score withdrawal symptoms every four hours of medication administration
- Rescue dosage administration [ Time Frame: Up to hospital discharge, anticipating an average of 4 weeks ] [ Designated as safety issue: No ]Number of rescue doses of additional medication
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Oral morphine sulfate
Oral morphine sulfate 0.4 mg/kg/day morphine every 3-4 hours as needed for Finnegan scores suggestive of Neonatal Abstinence Syndrome Other Name: morphine
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.
Sublingual Buprenorphine 15.9 µg/kg per day in 3 divided doses, titrated up or escalated down based upon standardized scoring for neonatal abstinence syndrome
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.
Neonatal abstinence syndrome is a condition that affects newborns who are exposed to chronic opioid drugs while they are in a mother's uterus (womb) prior to birth. The current standard of care treatment includes morphine sulfate. Buprenorphine is a drug used in adults to treat narcotic dependence and withdrawal, but has not yet been approved for use in newborns as a treatment alternative for Neonatal Abstinence Syndrome. This investigation is designed to measure if sublingual (under the tongue) buprenorphine is able to reduce hospital length of stay and decrease number of days of drug treatment currently required in treatment of NAS. Another goal will be to understand buprenorphine as a cost effective treatment for NAS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708707
|United States, Arizona|
|Banner Good Samaritan Medical Center NICU|
|Phoenix, Arizona, United States, 85006|
|Principal Investigator:||Gregory Martin, MD||Banner Good Samaritan Medical Center|