Efficacy & safety of standard Vs high flow rates of Nasal High Flow therapy in very preterm neonates- A randomized controlled trial

Surya Children Hospital1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2017年10月10日最近更新: 2021年11月11日

试验速览

阶段: 3 期
状态: 已完成
发起方: Surya Children Hospital
入组人数: 200
试验地点: 1
主要终点: HHHFNC failure rate -composite outcome defined by the need of a) CPAP support b) surfactant treatment c) mechanical ventilation

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

The primary purpose of the study would be to compare the failure rate of standard nasal flow rate (SFR) vs high nasal flow rate (HFR) initiated within 6 hrs of age in premature infants >= 28 weeks of gestation with respiratory distress syndrome. Eligible infants will be allocated to one of the two groups, (SFR Vs HFR) after obtaining written informed consent from the parents. With worsening respiratory distress, the nasal flow rate would be increased by 2 litres/min and would be considered for CPAP support, surfactant therapy or mechanical ventilation in that order.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator and Outcome Assessor Blinded

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 more than 28 weeks of gestation and/or more than 1 kg birth weight with respiratory distress and FiO2 requirement >30% within first 6 hours of birth.

排除标准

•Birth weight <1000 grams 2)Gestational age <28 weeks 3)Infant who already received surfactant 4)Pneumothorax on Chest X-ray 5)Shock requiring inotropic support, multi organ dysfunction and encephalopathy 6)Abnormalities of upper and lower airways precluding use of HHHFNC (Pierre-Robin, Treacher Collins, Goldenhar, choanal atresia, cleft lip/palate) 7)Serious abdominal, cardiac, or respiratory malformations including tracheal esophageal fistula, intestinal atresia, omphalocele, gastroschisis, or diaphragmatic hernia.

结局指标

主要结局

HHHFNC failure rate -composite outcome defined by the need of a) CPAP support b) surfactant treatment c) mechanical ventilation

时间窗: from birth until fifth day of postnatal age

次要结局

1.Duration of respiratory support(2.Duration of oxygen therapy.)

研究者

发起方

Surya Children Hospital

申办方类型

Other [Children hospital]

研究点 (1)

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