Effect of Umbilical Cord Milking Versus Delayed Clamping in Preterm Infants on Cerebral Oxygenation and Ductus Arteriosus Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- time of functional ductus arteriosus closure
研究概览
简要总结
All patients will be subjected to the following:
1-Umbilical cord milking or delayed cord clamping according to the ranamization table 2 serial measurement of cerebral tissue oxygenation 3- serial echocardiography for ductus arteriosus (DA)functional closure
详细描述
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Study Population: neonates born and admitted to Ain shams university neonatal intensive care units (NICUs).
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Inclusion criteria:
o Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.
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Exclusion criteria:
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Late preterm with gestational age 34-37 weeks.
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Term infants with gestational age > 37 weeks.
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NIRS data that was not obtained within 1st hour after birth.
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Congenital heart disease (other than DA or small atrial septal defects/patent foramen oval/ventriculi septal defects).
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Hypoxic-ischemic insult.
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Major congenital deformations. #All participants will be subjected to the following:
-
Infants will be considered to be randomized at the time of enrolment for:
o Delayed cord clamping (DCC) and Umbilical cord milking (UCM)
- Near-infrared spectroscopy (NIRS):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
all involved neonates will be randomized to DCC or UCM according to the randomization table and double-blinded method.
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational age (GA) of 28 - 34 weeks born and admitted to Ain shams university NICUs.
排除标准
- •Late preterm with gestational age 35-37 weeks.
- •Term infants with gestational age > 37weeks.
- •NIRS data that not obtained within 1sthour after birth.
- •Congenital heart disease (other than PDA or small atrial septal defects/patent foramen oval/muscularventriculoseptal defects).
- •Hypoxic-ischemic insult.
- •Major congenital deformations.
结局指标
主要结局
time of functional ductus arteriosus closure
时间窗: 6, 12, 18, 24, and 48 hours of life
performed by follow-up echocardiography using machine Mindary.M9 measuring changes from the baseline blood flow direction through the ductus arteriosus (DA) at 6, 12, 18, 24, 48 hours of life that helps to determine at which time the functional closure of ductus arteriosus occurs.
次要结局
- changes in cerebral tissue oxygenation by NIRS.(First hour of life for 10 minutes/ and for 2 hours on 12,24,84 hours of life)
- ductus arteriosus diameter(6, 12, 18, 24, and 48 hours of life)
研究者
walaa M Madkoor, MD [walaa madkoor]
Assistant fellow of pediatrics at Ahmed Maher teaching hospital
Ain Shams University