Evaluation of Dosing Chart Taking Into Account Age and Gender for Calculating the First Dose of Doxapram in Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
研究概览
简要总结
Doxapram is used to stimulate respiration. For a given dose, the fluctuations in concentrations observed in infants' blood may be wide, leading to a risk of lack of efficacy or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of this study is to compare a dosage regimen based only on patient's weight, to another one using a dosing chart taking into account weight, age and gender.
详细描述
Doxapram is a drug used to stimulate respiration in neonates prematurely born and failing to breathe. For a given dose, the fluctuations in concentrations of drug observed in infants' blood might be wide, leading to a risk of lack of efficacy of the treatment or of toxic effects. Two factors are linked to these fluctuations: age and gender. The aim of our study is to compare a dosage regimen based only on patient's weight, and another one using a dosing chart taking into account not only weight but also age and gender to prescribe the initial dose of doxapram. The final goal of this trial is to improve efficacy and tolerance of doxapram by minimizing the fluctuations in blood drug levels in premature neonates.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants (<37 weeks gestation)
- •More than 1 significant Apnea q 8h (> 20 sec or < 20 sec with bradycardia or desaturation)
- •Already treated with caffeine
排除标准
- •Intubation
- •congenital malformation
- •symptomatic apnea
研究组 & 干预措施
1
Treatment based on patient weight;
干预措施: Doxapram (Drug)
2
Treatment based on a chart taking into account weight, age and gender
干预措施: Doxapram (Drug)
结局指标
主要结局
Plasma level of Doxapram and its active metabolite (ketodoxapram) at 48 hours after the onset of treatment.
时间窗: 48 Hours
次要结局
- Efficacy (rate of significant apnea)(1 Week)
研究者
Jean Michel Hascoet
Professor
Maternite Regionale Universitaire