Delayed Cord Clamping in Rhesus Disease of the Newborn: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hematocrit value
研究概览
简要总结
The objective of this clinical trial is to investigate the effects of delayed cord clamping on hyperbilirubinemia, the need for phototherapy, neonatal intensive care (NICU) admission
详细描述
The study will include term or preterm infants born to Rh negative mother.
The enrolled infants will be randomized into two groups:
Group (1) will include infants with delayed cord clamping performed at 60 sec after birth Group (2) will include infants with early cord clamping within 15 seconds.
History and examination The data on the gender, gestational age, birth weight, length, head circumference, 5- minute Apgar scores, presence of jaundice requiring phototherapy or exchange transfusion, need for admission in neonatal intensive care unit, the presence of respiratory distress (RR > 60 breath per minute) ,and length of hospitalization will be recorded.
The enrolled infants will be followed either with their mothers in the nursery or in NICU. Regarding the mothers; maternal age, maternal weight, any diseases, medication, and mode of delivery, and postpartum hemorrhage requiring blood transfusion will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •term or preterm infants born to Rh negative mother
排除标准
- •Infants with Rh negative factor
- •major congenital malformation
- •fetal hydrops
- •short umbilical cord less than 25cm
- •nuchal cord
- •multiple gestation
- •unstable maternal hemodynamic condition
- •placenta abruption
- •placenta previa
- •uterine rupture
- •denied to participate
- •depressed neonates who will require immediate resuscitation
结局指标
主要结局
Hematocrit value
时间窗: 2 hours
Hematocrit will be measured at 2 hours of life (percent %)
次要结局
- Bilirubin level(24 hours)
研究者
Shaimaa Reda Abdelmaksoud
M.D. (Lecturer)
Benha University