Optimal Morphine Dosing Schedule for Neonatal Abstinence Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Enrollment Rate
研究概览
简要总结
Randomized pilot trial comparing scheduled morphine dosing with a weaning protocol to intermittent morphine dosing on an as-needed basis for newborns with neonatal abstinence syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborn greater than or equal to 35 weeks gestation
- •intrauterine opioid exposure
- •signs and symptoms of opioid withdrawal
排除标准
- •congenital anomalies or suspected genetic condition
- •co-morbid conditions that require sedation or analgesia due to clinical condition
- •ongoing need for respiratory support
研究组 & 干预措施
Standard
Infants randomized to the standard arm will receive morphine based on the current institutional treatment protocol: oral morphine 0.05 mg/kg/dose given every 3 hours, initiated if threshold Finnegan score is met. Once stabilized, dose will be weaned by 10% of peak dose per day until discontinuation.
干预措施: Morphine scheduled (Drug)
Study
Infants randomized to the study arm will receive oral morphine 0.05 mg/kg/dose as needed for an elevated Finnegan score. May receive morphine as frequently as every 3 hours if needed.
干预措施: Morphine PRN (Drug)
结局指标
主要结局
Enrollment Rate
时间窗: Prior to second dose of morphine, within 4 hours
Percentage of eligible subjects who were enrolled and randomized in the study
Drop Out Rate
时间窗: Through final follow-up call at 6 weeks of age
Percentage of enrolled subjects who do not complete participation
Number of Study Group Subjects Switched to Standard Arm
时间窗: 24 hours
Number of study group infants removed from study protocol and treated under standard care.
次要结局
- Length of Hospital Stay From Birth to Discharge(Until discharge, up to 6 weeks)
- Total Cumulative Morphine Exposure(Until discharge, up to 6 weeks)
- Peak Morphine Dose(Until discharge, up to 6 weeks)
- Length of Morphine Treatment(Until discharge, up to 6 weeks)
研究者
Anna Thomas
Assistant Professor of Clinical Pediatrics
Indiana University