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临床试验/CTRI/2024/11/076254
CTRI/2024/11/076254尚未招募不适用

Role of ROX index in predicting CPAP effectiveness in Neonates with Respiratory Distress Syndrome

Dayanand Medical college and Hospital Ludhiana1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年11月15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
220
试验地点
1
主要终点
To predict need for Surfactant therapy

研究概览

简要总结

Respiratory Distress occurs among 4-7% of all neonates and is the most common reason for  30-40% of admissions in the Neonatal intensive care unit. It is more common among preterm (30%) and post term (21%) than term neonates.

CPAP is a non-invasive type of respiratory support which can be delivered without endotracheal intubation though classical mechanical ventilators can also provide CPAP. It works by providing a continuous level of positive pressure to the airways which distends the lungs, overcomes collapse and improves ventilation.

ROX index has not been validated in neonates with RDS earlier so it  will help to predict CPAP failure in neonates with RDS using simple and easily accessible clinical parameters like SpO2, FiO2, and Respiratory Rate to help minimise morbidity and mortality in preterm neonates by doing early intervention in the form of giving surfactant therapy and mechanical ventilation. Hence the need for the study.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Premature babies Respiratory distress syndrome requiring CPAP.

排除标准

  • Term neonates Neonates requiring hospital stay of less than 24 hours Neonates having congenital malformations like trachea oesophageal fistula, diaphragmatic hernia etc and complex congenital heart diseases.
  • Outborn neonates.
  • Neonates intubated immediately and put on mechanical ventilation in labour room.

结局指标

主要结局

To predict need for Surfactant therapy

时间窗: Outcome will be assessed/estimated i.e. at baseline, 12 hours, 24 hours, 48 hours, and 72 hours after birth

次要结局

  • To predict the need for Mechanical ventilation in neonates using ROX index.(To predict the duration of hospital stay required .)

研究者

发起方
Dayanand Medical college and Hospital Ludhiana
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

GURDEEP SINGH DHOORIA

DAYANAND MEDICAL COLLEGE AND HOSPITAL, LUDHIANA

研究点 (1)

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