Evaluating the Efficacy and Safety of an Innovative and Affordable Goat Lung Surfactant for the treatment of Respiratory Distress Syndrome (RDS) in preterm neonates: a multi-site randomized clinical trial

All India Institute of Medical Sciences New Delhi0 个研究点目标入组 101 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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•Neonates born at the study sites and fulfilling all of the following criteria will be eligible for enrolment in the study
•1. Gestational age less than or equal to 32 completed weeks
•2. Onset of respiratory distress within six hours of age
•3. If baby meets criteria for surfactant replacement therapy:
•a. FiO2 needed is 40% or higher while the baby is on CPAP to maintain pre-ductal oxygen saturation between 90% to 95% or
•b. Baby needs intubation because of CPAP failure or severe respiratory distress
•(Chest X-ray is not mandatory for deciding the need for SRT).

•Neonates with any of the following criteria will be excluded:
•1.Gestation below 26 wk
•2.Babies with severe birth asphyxia as defined by the need for chest compressions and/or initial (umbilical arterial/or within 1 hour of birth) pH <7.0
•3. Major congenital malformations
•4. Prophylactic surfactant administration, i.e. administration of surfactant before the infant develops respiratory distress
•5.Air leak or pulmonary hemorrhage prior to enrollment
•6.Shock requiring vasopressor support prior to enrollment

发起方

All India Institute of Medical Sciences New Delhi