Oral Ibuprofen Versus Placebo in Management of Patent Ductus Arteriosus in Preterm Infants: A Double Blind, Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence of PDA Closure by Echocardiography
研究概览
简要总结
The management options of Patent Ductus Arteriosus are still controversial and differ between centers. Recently, conservative management has been gaining interest as the evidence of benefit from medical treatment in terms of mortality and morbidity is lacking.
This study will compare oral ibuprofen (the standard treatment) with the conservative treatment, in terms of ductal closure and morbidity and mortality at discharge in preterm neonates less than 34 weeks.
详细描述
A double-blinded, randomized, placebo-control non-inferiority trial was conducted in the neonatal intensive care unit (NICU) of Ain Shams University children's hospital, Cairo, Egypt.
Informed consent was taken from the parents or legal guardians before enrolment, after fully explaining to them the nature of the study. The approval of the Research Ethics Committee at Ain Shams University was also obtained.
All preterm neonates less than 34 weeks were assessed in the first 48 hours by clinical and echocardiographic examination by a cardiologist to detect PDA and exclude any congenital heart disease.
All neonates meeting the inclusion criteria will be randomized into one of two groups:
Medical treatment group and Placebo group. Targeted neonatal Echo was repeated after 5 days of the start of medical treatment by a neonatologist or a cardiologist to assess PDA closure.
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, Investigator)
入排标准
- 年龄范围
- 1 Hour 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≤ 34 weeks
- •PDA Size > 1.5 mm and predominantly left-to-right shunt
- •One of the following:
- •Signs of Pulmonary overflow: Left atrium/Aortic diameter ratio (LA/Ao), Left Ventricular End Diastolic Diameter (LVEDD).
- •Signs of Systemic Hypo perfusion: Absent or Reversed diastolic flow in the aorta, celiac/mesenteric, or Anterior Cerebral Artery (ACA)/ Middle Cerebral Artery (MCA)
排除标准
- •Chromosomal anomaly
- •Congenital heart defect, other than PDA and/or patent foramen ovale
- •Congenital or acquired gastrointestinal anomaly
- •Previous episodes of Necrotizing enterocolitis (NEC) or intestinal perforation
- •Active bleeding, especially intracranial or gastrointestinal hemorrhage
- •Contraindications to the use of ibuprofen
研究组 & 干预措施
Medical treatment Group
40 preterm neonates will receive Ibuprofen oral suspension
干预措施: Ibuprofen oral suspension (Drug)
Placebo Group
40 preterm neonates will receive oral placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of PDA Closure by Echocardiography
时间窗: Hospital discharge (approximately 3 months unless death occurs first)
Compare the incidence of PDA closure assessed by Echocardiography during hospitalization between the two groups
次要结局
- Incidence of Sepsis(Hospital discharge (approximately 3 months unless death occurs first))
- Incidence of Intraventricular hemorrhage (IVH)(Hospital discharge (approximately 3 months unless death occurs first))
- Incidence of death during hospitalization(Hospital discharge (approximately 3 months unless death occurs first))
- Incidence of Bronchopulmonary dysplasia (BPD)(Hospital discharge (approximately 3 months unless death occurs first))
- Incidence of Necrotizing Enterocolitis (NEC)(Hospital discharge (approximately 3 months unless death occurs first))
研究者
Nada Youssef
Assistant lecturer of pediatrics and neonatology
Ain Shams University