临床试验/CTRI/2024/04/065406

CTRI/2024/04/065406招募中2/3 期

Does surfactant mixed with budesonide in comparison with surfactant, reduce the incidence of BPD in very preterms- A Randomised control trial

Shaik Mohammed Munthakheem1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2024年4月16日最近更新: 2024年5月28日

试验速览

阶段: 2/3 期
状态: 招募中
发起方
入组人数: 120
试验地点: 1
主要终点: Death or BPD or BPD and Death

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Respiratory distress syndrome (RDS) in preterm infants is caused by a deficiency of pulmonary surfactant, which is necessary to reduce surface tension at alveoli. Increased surface tension, if untreated, may cause progressive airway collapse. Bronchopulmonary dysplasia (BPD) is one of the main chronic diseases of newborns born prematurely and, despite the development of medicine since its initial description more than 50 years ago, little has changed regarding the incidence of this disease.1-3

Compared with the conventional surfactant administration, surfactant mixed with budesonide was found to reduce

BPD
PDA
Post natal steriod use
ROP
NEC
IVH
Sepsis
Duration of ventilation
Duration of hospital stay

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 0.00 Day(s) 至 2.00 Day(s)（—）
性别: All

入选标准

•All inborn babies less than 30 weeks, weigth less than 1500 grams, age less than 48 hours, requiring invasive or non invasive respiratory support, clinical decision to give surfactant and consent obtained.

排除标准

•Infants with major congenital anomalies, birth asphyxia (Apgar score less than 4 at 5 minutes after birth), who had prolonged resuscitation, and lethal cardiopulmonary disorder were excluded.

结局指标

主要结局

Death or BPD or BPD and Death

时间窗: Death or discharge

次要结局

NEC,IVH,ROP,Sepsis,PDA, Use of post natal steriods(Death or discharge)

研究者

发起方

Shaik Mohammed Munthakheem

申办方类型

Other [Principal investigator]

责任方

Principal Investigator

主要研究者

Shaik Mohammed Munthakheem

Government medical college

研究点 (1)

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