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临床试验/CTRI/2024/10/075976
CTRI/2024/10/075976
尚未招募
3 期

High (greater than 0.40) versus Low (greater than 0.30) Fractional Inspired Oxygen Threshold for Surfactant Therapy in Preterm Infants with Respiratory Distress Syndrome- A Randomized Controlled Trial.

IMS AND SUM HOSPITAL1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年11月10日最近更新:

概览

阶段
3 期
状态
尚未招募
发起方
IMS AND SUM HOSPITAL
入组人数
128
试验地点
1
主要终点
To compare the need for mechanical ventilation in the first 72 hrs following surfactant adminstration between 2 groups.

概览

简要总结

preterm were major contributing for nicu admission ,in which major morbidity being respiartory disress syndrome,cornerstone mangement for respiratory distress syndrome is respiartory support(cpap/mechanical ventilator) and surfactant repalcement.we came long way from routine intubation and prophylatic surfactant admisnatration coupled with ongoing invasive mechanical ventilation,to the present day predominant approach of management mainly use of non inavsive support(cpap) and selctive surfactant admsinatration.most common parameter used is FIO2 thershold ,regrading thershold differnent bodies uses differnet fio2 thershold,we use fio2 thershold 30% (eurpoean guidelines 2022).but at this thershold there is possiblity of overuse of surfactant ,so this study was planned to bring optimal fio2 thershold for surfactant administration for babies stabilized on cpap.Aim of the study is to comapre the need for mechanical vetlation admistrating surfactant at high(0.40) versues low(0.30) fio2 thershold in preterm infants with respiratory distress syndrome ,with primary objective to compare the need for mechanical ventilation in the first 72hrs.

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 1.00 Day(s)(—)
性别
All

入选标准

  • Preterm Infants with gestation less than 36 weeks requiring CPAP respiratory support within 6 hours after birth.
  • Parental consent.

排除标准

  • Preterm infants requiring directly mechanical ventilation in initial hours after birth.
  • Preterm infants with gestation less than 25 weeks.
  • Infants with major congenital anomalies including nasopharyngeal pathology including cleft palate.
  • Infants who are hemodynamically unstable requiring inotropes.

结局指标

主要结局

To compare the need for mechanical ventilation in the first 72 hrs following surfactant adminstration between 2 groups.

时间窗: From surfactant adminstration to next 72 hrs

次要结局

  • To compare the duration of invasive /non-invasive/oxygen as respiratory support.(To compare the incidence of pneumothorax.)

研究者

发起方
IMS AND SUM HOSPITAL
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

MADINENI VENKAT NAVEEN

IMS AND SUM HOSPITAL(SOA University)

研究点 (1)

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