Early vs. Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure and Pain/Stress Reduction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of PDA Closures Related to Treatment With Ibuprofen
研究概览
简要总结
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.
详细描述
Infants with birth weight at <1200gm and/or <28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of <96 hrs old and >96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg on initial dose, followed 24 hours later by 5 mg/kg dose and then 24 hours later another dose of 5 mg/kg. An echocardiogram will be done prior to treatment and then within 48 hours after treatment.
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
- None
入排标准
- 年龄范围
- — 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight less than 1200gm
- •Less than 28 weeks gestational age
- •Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam
排除标准
- •Active Bleeding
- •Currently being treated for Persistent Pulmonary Hypertension (PPHN)
- •Cardiac anomalies
- •Chromosomal abnormalities
- •Endocrine, metabolic, renal, or hepatic disorders
研究组 & 干预措施
Early treatment
Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old
干预措施: Ibuprofen (Drug)
Late treatment
Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Number of PDA Closures Related to Treatment With Ibuprofen
时间窗: Within 48 hrs of ibuprofen round
Closure of the Patent Ductus in response to early or late treatment of ibuprofen was evaluated by echocardiogram. There is only one event (closure) possible per participant.
次要结局
- Plasma Catecholamines, Glucose, and Lactate Levels 1 and 6 Hours After Ibuprofen Administration(1 and 6 hours)