跳至主要内容
临床试验/CTRI/2022/05/042379
CTRI/2022/05/042379尚未招募不适用

Influence of surfactant administration on neonatal outcomes in a tertiary care neonatal unit in South India

Riya Asokan1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年10月5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
52
试验地点
1
主要终点
To compare the mortality rate of preterm infants who received surfactant with infants who did not receive surfactant.

研究概览

简要总结

This Study is a retrospective cross-sectional study to determine the influence of surfactant therapy in preterm neonates .Patients were dividedinto two groups: no surfactant and single (or) multiple doses. Decision to administer surfactant was based on established diagnostic criteria for

RDS adapted to a resource limited setting. The primary outcome was a composite of mortality and any of the major morbidities, including IVH

(grade 3 or 4), bronchopulmonary dysplasia or retinopathy of prematurity.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All inborn neonates with respiratory distress born between 23-34 weeks.

排除标准

  • Newborns >34 weeks gestation at birth All out born babies Infants who received surfactant for indications other than RDS (Eg; Pulmonary hemorrhage, Meconium aspiration) Infants with fatal congenital anomalies.

结局指标

主要结局

To compare the mortality rate of preterm infants who received surfactant with infants who did not receive surfactant.

时间窗: The outcomes will be assessed at the time of discharge / death. (However, all the date are collected retrospectively)

次要结局

  • To evaluate the following outcomes :(The major morbidities (ROP, BPD, IVH))

研究者

发起方
Riya Asokan
申办方类型
Other [self]

研究点 (1)

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