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临床试验/CTRI/2024/11/077192
CTRI/2024/11/077192尚未招募不适用

Feasibility of umbilical cord blood transfusion in preterm infants after delayed cord clamping

DrPoorna ovia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月26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
30
试验地点
1
主要终点
Success rate of umbilical cord blood collection more than 15ml per kg body weight after deleayed cord clamping.

研究概览

简要总结

HYPOTHESIS:Can we collect adequate amount of umbilical cord blood ( > 15ml/kg) after delayed cord clamping of 30 seconds among preterm neonates less than or equal to 30 weeks gestation or having estimated weight of less than 1200 grams and to check the quality of blood for transfusion till 21 days post collection,

JUSTIFICATION:Very low birth weight more so for extreme low birth weight babies require blood transfusion during NICU stay. the adult blood used for transfusion has less fetal hemoglobin and risk for oxidative stress and immunological reactions when compared to neonatal blood, if we are able to collect and store baby blood after delayed cord clamping and use it in the same baby, baby gets advantage of lesser transfusion related reactions.

BACKGROUND:Though studies have evaluated the safety of umbilical cord blood transfusins in preterm infants , the clinical use of autologous transfusion is limited and these trials have collected cord blood immediatly after cord clamping.

hence in this study we aim to assess the feasibility of umbilical cord blood collection after delayed cord clamping among extreme preterm and to asses the quality of collected blood for autologous transfusion in these infants.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • preterm babies less than or equal to 30 weeks or estimated fetal weight less than 1200 grams born by vaginal or caesarean section who consented before delivery.

排除标准

  • Clinical Chorioamnionitis Mother HIV positive Mother HbsAg positive Mother HBc Ag positive Rh isoimmunization Antenatally detected Major congenital anomalies Delayed cord clamping of 30 sec not possible due to the neonatal condition.

结局指标

主要结局

Success rate of umbilical cord blood collection more than 15ml per kg body weight after deleayed cord clamping.

时间窗: 30 seconds after birth.

次要结局

  • Proportion of umbilical cord blood units with satisfactory microbiological , haematological and biochemical quality available until 21 days of storage(2 years)

研究者

发起方
DrPoorna ovia
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrPoorna OviaA

Prashanth hospitals

研究点 (1)

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