A Randomized Comparison of Sublingual Buprenorphine to Morphine Sulfate in the Treatment of Neonatal Abstinence Syndrome (NAS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Hospital length of stay
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Morphine Sulfate (Drug)
Buprenorphine
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
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Hospital length of stay
时间窗: Up to hospital discharge, an anticipated average of 4 weeks
Number of days of hospital admission
次要结局
- 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)
- Withdrawal symptoms(Up to hospital discharge, usually occuring on average 4 weeks)
- Rescue dosage administration(Up to hospital discharge, anticipating an average of 4 weeks)