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临床试验/NCT06152796
NCT06152796尚未招募2 期

Paracetamol Versus Ibuprofen in Closure of Patent Ductus Arteriosus in Premature Neonates,at Upper Egypt

Assiut University0 个研究点目标入组 56 人开始时间: 2023年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
56
主要终点
Closure of PDA

研究概览

简要总结

To compare efficacy and safety of paracetamol and ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.

详细描述

The ductus arteriosus (DA) is an essential fetal blood vessel that connects the pulmonary artery to the aorta and serves to shunt blood away from the lungs into the umbilical placental circulation where gas exchange takes place.At birth, closure of the DA is a critical event in the transition to the postnatal circulatory pattern. However, there are situations in which DA closure does not occur or is delayed, resulting in the condition known as persistent patent DA (PDA) .

After birth, it usually closes within 48 h. A persistently PDA is diagnosed when the DA fails to close after 72 h.

PDA accounts for 5% to 10% of all congenital heart diseases. However, the incidence surges up to 60% in preterm infants and is inversely related to gestational age(GA) and birth weight.

The closure of the DA in full-term infants occurs in two steps. Initially, within the first few hours after birth,increased arterial PaO2 and decreased circulating prostaglandins allow the smooth muscle media of the ductus to constrict. As a result of the constriction, the inner muscle wall of the DA develops profound ischemic hypoxia which leads to the formation of vascular endothelial growth factor, transforming growth factor beta,and other inflammatory mediators and growth factors that transform the ductus into a non-contractile ligament.

The clinical consequences of PDA are related to the degree of left- to-right shunting through the PDA, with its associated change in blood flow to the lungs, kidneys, and intestine . This results in increased pulmonary blood flow and increased incidence of further comorbidities such as chronic lung disease, intraventricular hemorrhage(IVH), necrotizing enterocolitis (NEC), and retinopathy.Therefore, closure of the PDA is essential to prevent these complications and to improve both cardiorespiratory status and survival rate .

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 (Participant)

入排标准

年龄范围
28 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • preterm infants
  • with gestational age ≤37weeks
  • who had echocardiographically confirmed significant PDA.

排除标准

  • Preterm neonates
  • with major congenital anomalies,
  • life threatening sepsis,
  • urine output <1ml/kg/h in the last 24 h,
  • serum creatinine concentration >1.5 mg/dl, -platelet count <100,000/ml,
  • complex congenital heart,
  • or duct-dependent lesions.

研究组 & 干预措施

Paracetamol

Experimental

preterms receive oral/iv paracetamol at the dose of 15 mg/kg every 6 h for 3 days.

干预措施: Paracetamol (Drug)

Ibuprofen

Experimental

preterms receive oral ibuprofen at the initial dose 10 mg/kg, followed by 5 mg/kg after 24 and 48 h

干预措施: Ibuprofen (Drug)

结局指标

主要结局

Closure of PDA

时间窗: 6 days

Echo confirmed closure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Abdelfatah Abdelaal Abdelsamie

Doctor

Assiut University

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