The Role of Serial Echocardiography to Detect an Asymptomatic Patent Ductus Arteriosus (PDA) in Very Low Birth Weight (VLBW) Infants: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Number of days to regain birth weight.
研究概览
简要总结
The ductus arteriosus directs blood away from the pulmonary circulation and toward the systemic circulation during fetal life, then closes after birth. In preterm infants the incidence of spontaneous closure decreases with gestational age. Patent ductus arteriosus (PDA) increases the risks of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC). However, this association may not be a causal relationship.
Echocardiography is required to diagnose PDA. However, routine screening echocardiograms lead to detection of asymptomatic PDAs, for which the benefit of therapy remains unproven.
A randomized controlled trial has been designed in which 88 infants with birth weight less than or equal to 1250 grams and gestational age less than or equal to 30 weeks will be enrolled. The investigators' goal is to determine how screening echocardiography influences clinical management and outcomes in these infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birth weight less than or equal to 1250 grams
- •gestational age less than or equal to 30 weeks
- •postnatal age less than or equal to 72 hours
- •have a guardian or acceptable surrogate capable of giving consent on his/her behalf
排除标准
- •not considered viable
- •dysmorphic features or congenital malformations that adversely affect growth
- •have known or suspected congenital heart disease (other than PDA)
结局指标
主要结局
Number of days to regain birth weight.
时间窗: 1-4 weeks
次要结局
- Treatment for a PDA with indomethacin or surgical ligation.(3-6 months)
- Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.(3-6 months)
- Number of days to 120ml/kg/day of enteral feedings (full feeds).(3-6 months)
- Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.(3-6 months)
- Confirmed or suspected sepsis.(3-6 months)
- Ventilator days, number of days of positive airway pressure, and number of days in oxygen.(3-6 months)
- Worst stage of retinopathy of prematurity.(3-6 months)
- Day of death or discharge.(3-6 months)
研究者
Sara DeMauro
Assistant Professor of Pediatrics
University of Pennsylvania