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临床试验/CTRI/2024/10/075751
CTRI/2024/10/075751尚未招募不适用

Delayed cord clamping(DCC) at 1 minute versus 3 minutes in preterm neonates: A randomised controlled trial

IPGMER AND SSKM HOSPITAL1 个研究点 分布在 1 个国家目标入组 304 人开始时间: 2024年11月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
304
试验地点
1
主要终点
To determine venous hematocrit

研究概览

简要总结

BACKGROUNDA newborn experiences a variety of unique challenges at birth.  Significant cardiovascular changes occur and this transition in hemodynamics from fetal to extrauterine life is a vital phase in the early days of life. An increase in the   amount of newborn hemoglobin (Hb) and blood volume achieved through placental transfusion has the potential to improve cardiac output and tissue oxygen delivery during this critical period. Placental transfusion therefore has recently gained much importance. It involves the transfer of left over placental blood to the newborn baby during the initial minutes of life. There are three techniques to achieve this: delayed cord clamping (DCC), intact umbilical cord milking (I-UCM), and cut umbilical cord milking (C-UCM). Different placental transfusion strategies has shown to have significant  and hematological benefits in this vital period and beyond.

Despite being recommended as a routine practice, there are  concerns about the potentially harmful effects of DCC on neonatal and maternal outcomes such as higher incidences of polycythemia, neonatal hyperbilirubinemia (NNH), and the need for phototherapy, and postpartum hemorrhage in mothers with low certainty of evidence. However the systematic reviews evaluating these risks had low certainty of evidence owing to different methodologies of individual studies .

Therefore, to decide a uniform timing for cord clamping, and thus establish the optimal definition of DCC, more evidence needs to be generated. There is biological plausibility that the extra blood transfused by extending the time of  DCC upto 3 minutes would result in improved hematological parameters  and better neonatal transition. Limited number of studies are available in near term and term infants but  there is paucity  of data in preterm infants.

PURPOSE OF THE STUDY

·       Despite the reported benefits of  DCC,  the literature is scanty regarding the timing of delayed cord clamping .

·       No consensus exists as of now on the optimal cord clamping timing while practising delayed cord clamping  and more so in preterm neonates.

 In view of lack of consensus regarding optimal timing of DCC and scarcity of similar data in preterm infants from low- and middle-income countries (LMICs). , this study is designed to compare DCC for 1 minute versus 3 minutes with regards to hematological and clinical hemodynamic parameters in preterm neonates of 30-37 weeks gestation.  We hypothesize that DCC for 3 minutes will lead to higher serum hematocrit at 48 hrs of age compared to DCC for 1 min  in neonates of 30-37 weeks gestation

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 1.00 Day(s)(—)
性别
All

入选标准

  • Inborn neonates 300/7 to 366/7 weeks of gestation
  • Written informed parental consent obtained before participation in the study.

排除标准

  • Neonates born at gestation less than 30 weeks or more than or equal to 37 weeks ii.
  • Outborn neonates iii.
  • Multiple gestation iv.
  • Major lethal congenital anomalies or known/suspected chromosomal anomalies v.
  • Fetal hydrops vi.
  • Rh isoimmunization vii.
  • Cord prolapse, cord abnormalities such as true knots viii.
  • Shortumbilical cordlength ix.
  • No parental consent x.
  • Residence beyond 20 kms radius from our unit.

结局指标

主要结局

To determine venous hematocrit

时间窗: AT 48 HOURS OF LIFE

次要结局

  • a. Hct at 6 weeks of postnatal age(b. Bilirubin level at 12 , 48 hours of postnatal age.)

研究者

发起方
IPGMER AND SSKM HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

BIJAN SAHA

Associate Professor

研究点 (1)

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