TIME TO RE-EVALUATE THE KINDER GENTLER APPROACH TO PATENT DUCTUS ARTERIOSUS (PDA) IN THE PRETERM NEONATE
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Composite outcome of death or severe morbidity chronic lung disease [CLD]
研究概览
简要总结
The therapeutic approach to the patent ductus arteriosus (PDA) in the premature neonate remains controversial. Currently it is generally accepted to treat only hemodynamically significant PDAs. The current investigation aims to study the effect of treatment on PDAs of borderline significance via a prospective, randomized controlled trial of paracetamol in this group.
详细描述
In the neonatal intensive care unit of the Shaare Zedek Medical Center, preterm babies <30 wks. GA, are studied echocardiographically on day of life 3-4. Pending parental informed consent, those diagnosed with a PDA of borderline significance will be randomized to receive either paracetamol or placebo for three days, followed by a repeat echocardiogram. If the PDA remains of borderline significance, the treatment will be continued for an additional 4 days (1 week total). Paracetamol levels and liver functions will be assessed after the third day. Babies will be followed until discharge for subsequent PDA pathology; respiratory distress and chronic lung disease [CLD]; necrotizing enterocolitis [NEC]; retinopathy of prematurity [ROP].
The investigators' primary goal is to demonstrate a decrease in the composite outcome of death or severe morbidity chronic lung disease [CLD], as shown by decreased time on supplemental oxygen and assisted ventilation.
Secondary goals:
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To demonstrate a decrease in subsequently diagnosed hs PDA, including
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Decrease in the need for subsequent therapy for PDA closure
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Decrease in surgical PDA ligations
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To demonstrate a decrease in necrotizing enterocolitis (NEC) and/or ROP with treatment.
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To demonstrate no adverse effect on blood flow in anterior cerebral, superior mesenteric and renal arteries.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Days 至 6 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates < 30 weeks' gestational age PDA of borderline significance
排除标准
- •Infants not deemed likely to survive more than one week Infants with congenital heart malformations Infants with pulmonary hypertension and right to left ductal shunting
研究组 & 干预措施
Control Group
Treatment with placebo at a volume of 2.25 cc/kg/dose x 4/day to be given with feeds, or in place of feed when baby is receiving <2 cc/kg/feed.
干预措施: Placebo (Other)
Treatment Group
Treatment with paracetamol drops at 15 mg/kg/dose x 4/day. Drops will be diluted 1:15 in order to reduce osmolality. This will yield a dose of 2.25 ml/kg/dose, to be given with feeds, or in place of feed when baby is receiving <2 cc/kg/feed.
干预措施: Paracetamol drops (Drug)
结局指标
主要结局
Composite outcome of death or severe morbidity chronic lung disease [CLD]
时间窗: Day of life 3 until 40 weeks post-conception
Chronic lung disease will be assessed by time on supplemental oxygen and assisted ventilation.
次要结局
- Subsequently diagnosed hs PDA(Completion of study intervention until 40 weeks post-conception)
- Subsequent incidence of necrotizing enterocolitis (NEC) and/or retinopathy of prematurity (ROP)(Completion of study intervention until 40 weeks post-conception)
研究者
Cathy Hammerman
Director Div. Newborn Nurseries
Shaare Zedek Medical Center