CTRI/2015/07/005968
Other
Phase 2
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 sites101 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Preterm neonates with Respiratory Distress Syndrome
- Sponsor
- All India Institute of Medical Sciences New Delhi
- Enrollment
- 101
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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