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临床试验/CTRI/2024/09/073754
CTRI/2024/09/073754尚未招募3 期

TARGETED OXYGEN (60 PERCENT vs 30 PERCENT) FOR RESUSCITATION IN PRETERM NEONATES BETWEEN 26-32 WEEKS OF GESTATIONAL AGE: A RANDOMIZED CONTROL TRIAL

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年9月13日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
108
试验地点
1
主要终点
To determine the initial duration of respiratory support

研究概览

简要总结

Newborn resuscitation requires anticipation and preparation. It has been proven that term and late preterm newborns have lower short-term mortality when respiratory support during resuscitation is started with 21% oxygen (air) versus 100% oxygen. This has been attributed to lower oxygen toxicity and free radical damage. However, the same principle is difficult to apply on a preterm neonate, especially on very low birth weight neonates. This is because preterm neonates may need supplemental oxygen because of lung immaturity, but antioxidant defenses are also suboptimal until the third trimester. Moreover hypoxia and hyperoxia both can trigger lung injury in very preterm babies, thus prolonging the respiratory support and duration of stay. Very preterm infants often need oxygen supplementation to prevent hypoxia. Extremely preterm infants (i.e., those born below 28 +6 weeks gestation), despite advances in perinatal care, continue to be vulnerable to the consequences of both hypoxia and oxidative stress. Therefore, whereas, resuscitation with 21% has the potential to increase mortality, at the same time 100% oxygen during initial few minutes of life also has the potential to increase the morbidity due to free radical injury. A clinical equipoise hence exists for optimal oxygen use in resuscitation of preterm neonates. This study is hence planned to see the outcome of two oxygen concentrations in intermediate zone (30% and 60%) for delivery room resuscitation in preterm neonates less than 32 weeks of gestation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Preterm neonates between 26-32 weeks of gestational age.

排除标准

  • Preterm neonates with gross congenital anomalies.

结局指标

主要结局

To determine the initial duration of respiratory support

时间窗: Daily till discharge or death

次要结局

  • Total duration of respiratory support(Daily till discharge or death)
  • Common neonatal morbidities [Bronchopulmonary dysplasia stage ≥ 2 (as(per revised NICHD classification)Intraventricular hemorrhage grade (IVH) ≥)
  • All cause mortality(Daily till discharge or death)
  • Total duration of hospital stay(days)(Daily till discharge or death)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sushma Nangia

Lady Hardinge Medical College

研究点 (1)

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