Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in PDA size
研究概览
简要总结
This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.
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
- 23 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life.
排除标准
- •Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST> 150 U/L, ALT>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations
研究组 & 干预措施
Acetaminophen to close PDA
Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Change in PDA size
时间窗: 3 days
Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete.
Rate of PDA closure
时间窗: 3 days
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
次要结局
未报告次要终点
研究者
Ronnelle King
MD
Albany Medical College