Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Length of treatment
研究概览
简要总结
The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of treatment for NAS .
详细描述
Prospective randomized control trial. There will be 2 groups, control group and the intervention group. The control group will receive the standard of care used for NAS treatment currently in Cooper Hospital NICU and transitional nursery.
Morphine is used as the standard treatment and if the withdrawal symptoms are not well controlled, Phenobarbital may be added as a rescue therapy at that time. Hence, both the Morphine and Phenobarbital are part of the standard treatment at Cooper University Hospital for NAS. The intervention group will be treated with Clonidine for withdrawal symptoms of NAS and if not well controlled with Clonidine then Phenobarbital will be added as a rescue therapy.
All of the medications, Clonidine, Morphine and Phenobarbital will be administered orally via syringe, prior to initiation of a feed.
The following are the treatment guidelines (see attached for more details):
- Observe babies exposed to narcotics in utero in the hospital for a minimum of 72 hours to 5 days prior to discharge, to monitor for possible withdrawal symptoms.
- Once infants are exhibiting signs of withdrawal, the infants will be scored using Modified Finnegan Scoring System every four hours after feeds:
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)
盲法说明
The family of the patient (baby), medical provider team and nursing will be masked to the specific arm. Investigator, unless is an active medical provider at the time, and pharmacist will not be masked.
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born at Cooper University Hospital
- •Greater than or equal to 35 weeks gestation age
- •Admitted to the NICU or Transitional nursery
- •Mothers admitted to using illicit substances or prescription medications (which can result in withdrawal symptoms) while pregnant and/or had a positive urine drug screen during pregnancy.
- •Babies being started on medication to control withdrawal symptoms of NAS.
- •No congenital anomalies or neurologic condition (i.e. hypoxic-ischemic encephalopathy, seizures, meningitis etc.)
排除标准
- •Premature infants <35 week gestational age
- •Infants with major congenital abnormalities
- •Blood pressure instability
- •Major medical conditions
研究组 & 干预措施
Clonidine
Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours
干预措施: Clonidine (Drug)
Morphine
Morphine Sulfate at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours
干预措施: Morphine Sulfate (Drug)
结局指标
主要结局
Length of treatment
时间窗: From initiation of medical treatment through last dose of medication given, up to 100 days
Duration of treatment of Neonatal Abstinence Syndrome with medication/pharmacological treatment from first day initiated until medication has been stopped or patient discharged home
次要结局
- Length of stay(From birth through discharge from the hospital, up to 100 days.)
研究者
Alla Kushnir
Associate Professor of Pediatrics, Principal Investigator
The Cooper Health System