A Randomized, Open Label Clinical Trial of Buprenorphine in the Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines or Are Breastfeeding
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Length of treatment
研究概览
简要总结
The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.
详细描述
Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by ~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 37 weeks gestation
- •Exposure to opioids in utero
- •Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
- •Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.
排除标准
- •Major congenital malformations and/or intrauterine growth retardation defined as birth weight <2200 gm
- •Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
- •Hypoglycemia requiring treatment with intravenous dextrose
- •Bilirubin >20 mg/dL (The need for phototherapy is not exclusionary)
- •Seizure activity or other neurologic abnormality
研究组 & 干预措施
sublingual buprenorphine
Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
干预措施: sublingual buprenorphine (Drug)
oral morphine
Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
干预措施: oral morphine (Drug)
结局指标
主要结局
Length of treatment
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 5 weeks
This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.
次要结局
- Length of hospitalization(Patients will be followed for the duration of hospital stay, an expected average of 5 weeks)
- Number of patients requiring supplemental phenobarbital treatment(Patients will be followed for the duration of hospital stay, an expected average of 5 weeks)
- Number of participants with adverse events as a measure of safety and tolerability(Patients will be followed for the duration of hospital stay, an expected average of 5 weeks)