Prophylactic Acetaminophen for Prevention Intraventricular Hemorrhage in Premature Infants
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.
研究概览
简要总结
The purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of IVH in premature infants.
详细描述
It will be a double-blind randomized control trial, single center. The study will include neonates with a gestational age of less than or equal 32 weeks and a birth weight of less than or equal 1500 g, and will randomly assigned to two treatment groups (see below).
Infants will be randomized to equal-sized groups using block randomization with blocks of four. Stratified randomization for gender and gestational age will be included in the randomized blocks. Gestational age will be divided into two categories: 23 weeks +0 day to 27 weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. Gender (2) × gestational age (2) will give 6 strata, requiring 6 separate random number lists to achieve randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature baby less than or equal 32 week and birth weight less than or equal 1500 g
排除标准
- •Out-born babies, infants with major congenital anomalies, babies have IVH III, IV, High expectancy of early death
研究组 & 干预措施
acetaminophen group
Babies who took acetaminophen
干预措施: Acetaminophen (Drug)
Placebo group (Dextrose 5)
Babies who took placebo
干预措施: Dextrose 5 (Drug)
结局指标
主要结局
The incidence of intraventricular hemorrhage (IVH will be graded by Papile score) among the infants on acetaminophen compared to the infants on placebo.
时间窗: within the first week of age
次要结局
- The incidence of neonatal sepsis in the premature babies who received acetaminophen(Corrected 40 weeks of gestational age or time of discharge will be used)
- The incidence of Necrotizing Enterocolitis (NEC) in the premature babies who received acetaminophen(Corrected 40 weeks of gestational age or time of discharge will be used)
- The incidence of bronchopulmonary dysplasia (BPD) in the premature babies who received acetaminophen(Corrected 40 weeks of gestational age or time of discharge will be used)
研究者
Mountasser Al-Mouqdad
NICU consultant
King Saud Medical City