Clonidine as Adjunct to Morphine in the Management of Term and Near Term Infants With Neonatal Abstinence Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Duration of Pharmacotherapy for NAS
研究概览
简要总结
This is a prospective randomized double blinded study comparing the effect on duration of pharmacologic treatment and duration of hospital stay when using clonidine at 12 µg/kilogram/day as an adjunct to oral morphine as compared to morphine monotherapy in the management of term and near term infants with neonatal abstinence syndrome (NAS)
详细描述
Neonatal abstinence syndrome (NAS) is an emerging epidemic and has lead to a tremendous increase in cost of medical care. Opioids are the mainstay of treatment for NAS although there are concerns about possible short-term and long-term effects including but not limited to adverse neurodevelopmental outcomes. Other drugs such as clonidine, phenobarbitone, methadone and buprenorphine have been evaluated to limit the postnatal exposure to opioids in these infants. Clonidine is an alpha 2 receptor and can lessen withdrawal manifestations. The addition of clonidine at 6 µg/kilogram/day to morphine in the management of NAS has been shown to reduce the duration of pharmacotherapy by about 27% in a previous study.
A recent pilot study reported reduction of treatment duration for NAS with clonidine (12 µg/kilogram/day) monotherapy as compared to morphine monotherapy. The study reported no adverse effects in study subjects at the doses used in the study. The investigators hypothesize that there will be a minimum of 30% reduction in the treatment duration with 12 µg/kilogram/day clonidine used as adjuncts to standard morphine treatment as compared to morphine monotherapy in the management of term and near term infants with 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
- 36 Weeks 至 45 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Requiring neonatal intensive care unit (NICU) admission for management of neonatal abstinence syndrome
- •Gestational age greater than or equal to 36 weeks
- •Less than or equal to 48 hours of treatment with morphine for NAS
排除标准
- •Presence of seizures
- •Congenital malformations, genetic syndromes or the presence of TORCH infections
- •Major medical problems
- •Heart rate and/or blood pressure instability
研究组 & 干预措施
clonidine
Clonidine is started at 6mcg/kg/day and increased to 12 mcg/kg/d for the duration of the study period
干预措施: Clonidine (Drug)
Placebo
Placebo solution will be given for the duration of the study period
干预措施: Placebo (Drug)
结局指标
主要结局
Duration of Pharmacotherapy for NAS
时间窗: From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days
The length of time in days from the initiation of pharmacotherapy on day 1 until the medication has been stopped
次要结局
- Total Number of Episodes of Blood Pressure (mm of Hg) Variability(From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days)
- Average Daily Dose of Oral Morphine Over Hospital Stay(From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days)
- Maximum Dose of Morphine Used(From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days)
- Duration of Hospital Stay(From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days)
- Total Number of Episodes of Heart Rate Variability (Heart Beats/Min)(From beginning of morphine therapy during NICU admission until discharge from the hospital, up to 100 days)
研究者
kunal gupta
Assistant Professor
Hennepin County Medical Center, Minneapolis