Alternative Acetaminophen Treatment of the Hemodynamivally Significant Patent Ductus Arteriosus in Preterm Neonates Who Are Not Candidates for Enteral Administration: A Pilot Study
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ductal closure
研究概览
简要总结
Early targeted treatment of a hemodynamically significant patent ductus arteriosus (hsPDA) during the first week of life in preterm neonates is often recommended. Our standard first line therapeutic approach is enteral acetaminophen. However many extremely low birth weight infants may be on limited or no feeds when PDA closure is determined to be indicated, thus restricting the use of enteral acetaminophen. Several studies have suggested that intravenous acetaminophen is less effective than enteral. Thus, in this study, we propose to compare two alternative modes of administration when enteral acetaminophen is not an option.
详细描述
Once parental consent for entrance into the study is obtained, eligible babies will be randomized to receive either IV acetaminophen (perfalgen) by continuous infusion at 2.5 mg/kg/h following a loading dose of 15 mg /kg/ over 20 minutes or rectal acetaminophen at 15 mg/kg every 6 hours for a period of 3 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Days 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn preterm neonates, < 1000 gm birth weight; < 28 weeks' gestational age; who are admitted to the neonatal intensive care unit of the Shaare Zedek Medical Center and are diagnosed with a hemodynamically significant patent ductus arteriosus within the first week of life and who are on limited or no enteral feeds -
排除标准
- •Other congenital heart disease, major congenital anomalies, sepsis; and/or NEC.
研究组 & 干预措施
Continuous IV Acetaminophen
Intravenous Infusion
干预措施: Intravenous Infusion (Drug)
Rectal Acetaminophen
Rectal Solution
干预措施: Rectal Solution (Drug)
结局指标
主要结局
Ductal closure
时间窗: Up to 1 week following treatment
Follow-up echocardiogram showing closed ductus arteriosus
次要结局
- PDA Ligation(Completion of study intervention until 40 weeks post-conception)