Evaluation of Efficacy of Methadone Versus Morphine for Treatment of Neonatal Abstinence Syndrome (NAS).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Days of Treatment With Opioid Medication
研究概览
简要总结
Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.
详细描述
The purpose is to compare treatment of NAS with two different initial medications with primary outcome of (1) reducing the duration of opiate medication treatment and (2) reducing the number of infants treated with a second medication.
Design is a randomized, blinded comparison. The comparison is between methadone and morphine
Research Design:
a. Procedures: NAS scoring is currently done on infants meeting the inclusion criteria. NAS scores are done every 2 hours for 24 hours and then every 4 hours when awake after feeding for the duration of observation and treatment.
i. NAS scores may indicate more than withdrawal. Conditions such as colic (hypercaloric formula, transient lactose intolerance), reflux, diaper irritation, prenatal SSRI exposure, and nicotine withdrawal or baseline irritability may influence the variability of scores. Decisions based on the NAS scores should take into account these factors for the infant.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8 hour time period, AND
- •ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria, AND
- •iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND
- •iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.
排除标准
- •i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.
- •ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,
- •iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.
- •iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course
- •v. Mother consistently taking prescribed benzodiazepine at the time of delivery
研究组 & 干预措施
methadone
Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:
NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose
- Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)
- Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.
- If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
干预措施: Methadone (Drug)
morphine
Morphine (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:
NAS Score Morphine 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose
- Maximum dose of morphine will be 0.2 mg/kg/dose. (NeoFax)
- Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 6 hours, until NAS scores are consistently <8 for 48 hours.
- If the maximum dose of morphine is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.
干预措施: Morphine (Drug)
结局指标
主要结局
Days of Treatment With Opioid Medication
时间窗: From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months
The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs
次要结局
- Second Drug for Withdrawal(From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months)
研究者
Mark S Brown, MD
Chief of Pediatric Service, Neonatalogy
Eastern Maine Medical Center