Neonatal Abstinence Syndrome, Neonatal Withdrawal Syndrome
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGBuprenorphine
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.
DRUGMorphine 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.
Sponsors
Pediatrix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* Infants of corrected gestational age ≥37 weeks * Chronic opioid exposure in utero * Signs and symptoms of NAS requiring treatment * 2 consecutive Finnegan scores ≥8 or any single score ≥12
Exclusion criteria
* Concomitant maternal benzodiazepine or alcohol use 30 days prior to enrollment * Life-threatening congenital malformations * Intrauterine growth retardation * Seizure activity or congenital neurologic abnormalities * Concomitant neonatal use of Cytochrome P450 inhibitor or inducers prior to treatment * Inability of mother's consent due to altered mental status or comorbid psychiatric disorder * Neonatal administration of morphine prior to enrollment into study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | Up to hospital discharge, an anticipated average of 4 weeks | Number of days of hospital admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse or serious adverse events | Up to hospital discharge, with length of stay currently averaging approximately 4 weeks | — |
| Cost efficiency of buprenorphine | At least 48 prior to hospital discharge, with anticipated discharge averaging to be 4 weeks | Cost of buprenorphine as a product of number of days of administration |
| Withdrawal symptoms | Up to hospital discharge, usually occuring on average 4 weeks | Finnegan methodology to score withdrawal symptoms every four hours of medication administration |
| Rescue dosage administration | Up to hospital discharge, anticipating an average of 4 weeks | Number of rescue doses of additional medication |
Countries
United States
Outcome results
None listed