Exogenous surfactant obtained from goat lungs for treating respiratory difficulty due to lack of surfactant in preterm neonates

Phase 2

• Conditions: Health Condition 1: null- Preterm neonates with Respiratory Distress Syndrome

• Registration Number: CTRI/2015/07/005968
• Lead Sponsor: All India Institute of Medical Sciences New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-10-19
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 101

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BPD free survivalTimepoint: 36 weeks of post-menstrual age which means an postnatal age of 4 to 10 weeks after birth.