Pharmacological Treatment of Narcotic Neonatal Withdrawal
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Duration of treatment
研究概览
简要总结
Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.
详细描述
Background: Neonatal narcotic abstinence syndrome is an important medical, social and financial problem. Several drugs are used to treat the withdrawal symptoms in neonates that have been exposed to opiates in utero, but there is no consensus which one is best.
Goal: Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.
Methods: Neonates born after 34 completed weeks of gestation with meconium proven antenatal opiate exposure and parental informed consent are included. Infants with severe malformation are excluded. Each infant is assessed every eight hour by a modified Finnegan score. When 9 points are exceeded drug treatment is started and dose increased stepwise according to the score. The masqued solution applied orally contains morphine, phenobarbital or chlorpromazine. When the maximum dose does not reduce the score, a second randomisation and one of the two remaining drugs is added, again in a blinded way.
A total of 120 infants, 40 in each group will be included in the study.
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
- 1 Hour 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of mothers who consumed opiates during pregnancy
- •Born after 34 completed weeks of pregnancy
- •Parents' informed consent
排除标准
- •Preterm birth before 34 0/7 gestational weeks
- •Severe malformation
- •Illness requiring respiratory assistance or catecholamines
- •Negative meconium drug test
研究组 & 干预措施
Phenobarbital
Phenobarbitone loading dose 10 mg/kg body weight maintenance dose 0.83 mg/kg body weight every 4 hours
干预措施: Phenobarbital (Drug)
Chlorpromazine
Chlorpromazine loading dose 0.5 mg/kg body weight maintenance dose 0.25 mg/kg every 4 hours
干预措施: Chlorpromazine (Drug)
Morphine
Morphine (tinctura opii) 0.25 mg/kg body weight every 4 hours
干预措施: Morphine (Drug)
结局指标
主要结局
Duration of treatment
时间窗: 0 to 42 days
Treatment is reduced stepwise until withdrawal symptoms have gone
次要结局
- Weight gain(through study completion, up to 10 weeks)
- Treatment failures (need for adding second medication)(through study completion, up to 10 weeks)
- Incidence of convulsions(Whole time of hospitalisation (up to 10 weeks))