Patent Ductus Arteriosus (PDA) Screening Trial
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
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.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- The Hospital of the University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19107
- Pennsylvania Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- not considered viable
- dysmorphic features or congenital malformations that adversely affect growth
- have known or suspected congenital heart disease (other than PDA)
学习计划
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Nondisclosure
|
Subjects will be randomized to nondisclosure of screening echocardiogram results.
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有源比较器：Disclosure
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Subjects will be randomized to disclosure of screening echocardiogram results.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of days to regain birth weight.
大体时间：1-4 weeks
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1-4 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Treatment for a PDA with indomethacin or surgical ligation.
大体时间：3-6 months
|
3-6 months
|
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Necrotising enterocolitis (NEC) or >48 hours of NPO status for suspected NEC or feeding intolerance.
大体时间：3-6 months
|
3-6 months
|
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Number of days to 120ml/kg/day of enteral feedings (full feeds).
大体时间：3-6 months
|
3-6 months
|
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Ventilator days, number of days of positive airway pressure, and number of days in oxygen.
大体时间：3-6 months
|
3-6 months
|
|
Worst grade of intraventricular hemorrhage and presence of periventricular leukomalacia.
大体时间：3-6 months
|
3-6 months
|
|
Confirmed or suspected sepsis.
大体时间：3-6 months
|
3-6 months
|
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Worst stage of retinopathy of prematurity.
大体时间：3-6 months
|
3-6 months
|
|
Day of death or discharge.
大体时间：3-6 months
|
3-6 months
|
合作者和调查者
调查人员
- 研究主任：Barbara Schmidt, MD、University of Pennsylvania/Children's Hospital of Philadelphia
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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