A Randomized Controlled Trial of Different Nasal Interfaces on the Safety and efficacy of Nasal Intermittent positive Pressure Ventilation in Preterm newborn

Institute of Post Graduate Medical Education and Research Department of Neonatology0 个研究点目标入组 210 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Preterm newborn (gestational age of <37 completed weeks at birth) requiring NIPPV as primary respiratory support within 6 h of birth .Thus any preterm baby having respiratory distress within 6 h of birth, objectified as Silverman score of more than 3, will be eligible for non-invasive positive pressure ventilation.
•2.Preterm newborn requiring NIPPV after extubation within first 7 days of life.Thus
•any preterm baby undergoing extubation will also be eligible and will be supported with non-invasive positive pressure ventilation as per study protocol

•1.Presence of lethal congenital malformation or suspected chromosomal anomaly
•2.Outborn preterm infants
•3.Contraindications of non-invasive ventilation (shock requiring inotropes, cleft lip and palate, choanal atresia, severe perinatal asphyxia with APPGAR at 5 min of 3 or less)
•4.Parental refusal of consent for participation in the study
•5.Babies already on any form of non-invasive ventilation (continuous positive airway pressure or non-invasive positive pressure ventilation or heated humidified high flow nasal cannula) before randomization. Thus baby who is already on continuous positive airway pressure and require because of continuous positive airway pressure failure will not be included in the study.

发起方

Institute of Post Graduate Medical Education and Research Department of Neonatology