NCT01753843已完成不适用
A Randomised Controlled Trial to Evaluate the Role of Brief Delay in Cord Clamping in Preterm Neonates (34-36weeks) on Short Term Neurodevelopmental Outcome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- short term neurobehavioral outcome
研究概览
简要总结
RESEARCH HYPOTHESIS Brief delay(>30 sec to <60 sec ) in cord clamping as compared to early cord clamping (< 20 sec) leads to a better short term neurobehavioural outcome in preterm (34-36 wks) neonates when assessed by neurobehavioral assessment of preterm infants (n.a.p.i.) at 37 weeks of post conceptional age
详细描述
Delayed cord clamping (DCC) : Well described phenomenon in term infants .
- The optimal timing of clamping of umbilical cord in preterm infants : A subject of debate.
- Even a brief delay in cord clamping leads to an additional transfer of iron amounting to 40-50 mg/kg which may prevent iron deficiency.¹
- This low cost intervention can have significant public health importance in resource constrained settings.
- The effect of this intervention on neurobehaviour of preterm neonates has not been assessed.
- This aspect has been identified by WHO and Cochrane as a potentially researchable area
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
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All preterm deliveries -infants born at 34 weeks 0 days to 36 weeks +6 days gestational age as estimated by last menstrual period or early ultrasound scan.
- •Infants delivered vaginally or by caesarean section in cephalic presentation
- •Singleton pregnancy
- •Parental consent
排除标准
- •Fetus with gross congenital anomaly
- •Fetus with hydrops
- •Rh negative pregnancy
研究组 & 干预措施
early cord clamping
Active Comparator
cord clamping within 20 sec
干预措施: early cord clamping (Procedure)
brief delay in cord clamping
Experimental
cord clamping delayed by 30 to 60 seconds
干预措施: Brief Delay in cord clamping (Procedure)
结局指标
主要结局
short term neurobehavioral outcome
时间窗: at 37 weeks post conceptional age
using N.A.P.I (neurobehavioural assessment of preterm infant)
次要结局
- measuring cord hematocrit(at birth)
研究者
DR. VIKRAM DATTA
Principal Investigator
Lady Hardinge Medical College
研究点 (1)
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