NCT02750228已完成不适用
Patent Ductus Arteriosus Post NICU Discharge in Premature Infants: A Prospective Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 208
- 试验地点
- 16
- 主要终点
- Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA
研究概览
简要总结
The purpose of this study is to track post-discharge outcomes on prematurely born infants who are discharged from the NICU with a patent ductus arteriosus (PDA). Investigators plan to report on the spontaneous closure rate as well as the incidence of pulmonary and/or cardiac events in these infants. The goal is to identify risk factors associated with adverse outcomes in prematurely born infants who are sent home with a PDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of informed consent and authorization for participation.
- •Estimated gestational age of 32 weeks or less.
- •Active diagnosis of a PDA at discharge.
- •At least one echocardiogram obtained during hospital stay documenting/ confirming PDA diagnosis.
- •Parental agreement to provide follow-up information on their child.
- •Cardiologist and/or Pediatrician willing to provide follow-up information on enrolled infants.
排除标准
- •No known major congenital anomalies (inborn error of metabolism, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, multiple congenital anomalies).
- •Chromosomal / genetic disorders - Inherited metabolic disorders (Aa, fat or carbohydrate), Trisomies, Turner's syndrome,Vater's syndrome, CHARGE, DiGeorge or other 22q11 deletions, Major chromosomal duplications, deletions detectable on high resolution karyotype (not microarray).
- •Parent(s) unwilling to participate in follow-up.
结局指标
主要结局
Number of subjects that have a report of a spontaneous closure of PDA, medication intervention for closure of PDA or surgical intervention for closure of PDA
时间窗: 18 months
次要结局
- Number of subjects with or without a closure of PDA that have heart failure, pulmonary arterial hypertension, a need for respiratory support and death(18 months)
研究者
研究点 (16)
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