Individualized Management Over Routine Intervention: Evidence Against Early Ibuprofen for PDA From Combined Retrospective and Meta-Analytic Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 541
- 试验地点
- 1
- 主要终点
- Number of Participants with PDA Closure
研究概览
简要总结
This retrospective cohort study compares ibuprofen treatment versus expectant management for hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. Data were collected from preterm infants with hsPDA admitted to the Department of Neonatology, Shengjing Hospital of China Medical University between June 2020 and June 2025. A total of 541 infants were included: 241 received ibuprofen and 300 received expectant management (no routine pharmacological closure, supportive care only). The primary outcome is PDA closure rate. Secondary outcomes include bronchopulmonary dysplasia (BPD), mortality, pulmonary hypertension, renal insufficiency, neonatal pneumonia, retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), pulmonary hemorrhage, and gastrointestinal bleeding. Analyses are stratified by gestational age (<28 weeks, 28-33 weeks, 33-37 weeks) and adjusted for sex, multiple gestation, and maternal factors. The study aims to provide real-world evidence on the risks and benefits of ibuprofen closure in different gestational age subgroups.
详细描述
Background: Patent ductus arteriosus (PDA) is common in preterm infants. When hemodynamically significant (hsPDA), it may lead to pulmonary overcirculation, systemic hypoperfusion, and increased risk of bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), and other neonatal morbidities. Pharmacological closure with cyclooxygenase inhibitors such as ibuprofen is often used, but the benefits of routine closure remain controversial, particularly across different gestational age groups. Expectant management (allowing spontaneous closure without drugs) has gained interest, but comparative data are limited.
Objectives:
To compare ibuprofen versus expectant management for PDA closure and neonatal outcomes in preterm infants with hsPDA.
To examine effect modification by gestational age (<28 weeks, 28-33 weeks, 33-37 weeks).
To explore associations with sex, multiple gestation, and maternal factors. Study design: Single-center retrospective cohort study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 23 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Preterm infants (gestational age <37 weeks) with echocardiographically confirmed hemodynamically significant patent ductus arteriosus (hsPDA)
- •Admitted to the Department of Neonatology, Shengjing Hospital of China Medical University between June 2020 and June 2025
排除标准
- •- Major congenital anomalies or chromosomal disorders
- •Congenital heart disease other than PDA
- •Contraindications to ibuprofen (e.g., renal failure, necrotizing enterocolitis)
- •Missing outcome data
- •Received other PDA pharmacotherapy before study intervention
研究组 & 干预措施
Expectant Management Group
Preterm infants with hsPDA who received no routine pharmacological closure, only fluid restriction, diuretics, or supportive care. n=300.
Ibuprofen Group
Preterm infants with hsPDA who received ibuprofen (oral or intravenous) at standard neonatal dosing. n=241.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of Participants with PDA Closure
时间窗: At day 7 after intervention start (or equivalent time point for expectant management group)
Proportion of preterm infants with echocardiographically confirmed closure of hemodynamically significant patent ductus arteriosus (hsPDA).
次要结局
- Number of Participants with Bronchopulmonary Dysplasia (BPD)(At 36 weeks postmenstrual age (measured between 35+0 and 36+6 weeks))
- Number of Participants who Died (All-cause Mortality)(From birth to hospital discharge, up to 28 days)
- Number of Participants with Pulmonary Hypertension(During initial hospitalization, up to 12 weeks)
- Number of Participants with Renal Insufficiency(Within first 7 days after intervention start)
- Number of Participants with Neonatal Pneumonia(During initial hospitalization, up to 12 weeks)
- Number of Participants with Retinopathy of Prematurity (ROP)(Prior to discharge or at 40 weeks postmenstrual age, up to 16 weeks)
- Number of Participants with Intraventricular Hemorrhage (IVH)(Within first 14 days of life)
- Number of Participants with Pulmonary Hemorrhage(During initial hospitalization, up to 12 weeks)
- Number of Participants with Gastrointestinal Bleeding(Within first 7 days after intervention start)
研究者
Xinyang Ma
Associate Professor of Neonatology
Shengjing Hospital