Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Closure of arterial duct - yes / No
研究概览
简要总结
There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants.
The investigators conducted this open label non randomized and non control study to try to support that report.
详细描述
In-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. Since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left.
After birth, systemic pressure rises and pulmonary pressure declines. As oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. In preterm infants, the arterial duct may remain open after birth. At this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion.
Ibuprofen is the treatment of choice for PDA in preterm infants. Yet, ibuprofen is not effective after two weeks of age. Moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. Surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails.
Lastly, there was a report that acetaminophen may have a role in pharmacological closure of PDA in preterm infants.
The investigators conducted this open label non randomized and non control study to try to support that report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with symptomatic PDA who could not be treated with ibuprofen
排除标准
- 未提供
研究组 & 干预措施
Ibuprofen
If there is a PDA, that should be treated, and the infant is less than 2 weeks of age, we use ibuprofen, as this is the gold standard in literature.
干预措施: Ibuprofen (Drug)
Surgical closure of PDA
Infants with symptomatic PDA, who had to be treated, but could not be treated by ibuprofen, either due to age (> 2 weeks) or due ibuprofen contraindications (thrombocytopenia or renal failure), whose could not be treated by paracetamol (either because of parents' refuse or because they were on nothing per os protocol due to other disease), for whom surgery was the treatment of choice to close the arterial duct.
干预措施: Closure of PDA (Procedure)
Paracetamol
Infants with symptomatic PDA who could not be treated with ibuprofen, and their parents agreed and they could be treated with paracetamol.
干预措施: Paracetamol (Drug)
结局指标
主要结局
Closure of arterial duct - yes / No
时间窗: 1 week
Echo-cardiogram that will give exact answer to the question: "was the arterial duct closed"?
次要结局
- Need for surgical closure of arterial duct(1 week)
研究者
Erez Nadir, MD
Senior neonatologist
Hillel Yaffe Medical Center