Efficacy and Safety of Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates

• Status: Unknown status
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of Cadisurf (goat lung surfactant extract) as compared to Survanta (beractant) in the treatment of respiratory distress syndrome in preterm neonates (with gestation of 26 to 32 weeks).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ramesh K Agarwal
• Collaborators: All India Institute of Medical Sciences, New Delhi; Chacha Nehru Bal Chikitsalya, Delhi; Government Medical College, Chandigarh; Institute of Child health and Hospital for Children, Chennai; Jawaharlal Institute of Postgraduate Medical Education & Research; King Edward Memorial Hospital, Mumbai; King Edward Memorial Hospital, Pune; Lade Hardinge Medical College, New Delhi; Lady Hardinge Medical College; Lokmanya Tilak Municipal General Hospital; Lokmanya Tilak Municipal General Hospital, Mumbai; Maulana Azad Medical College, New Delhi; Postgraduate Institute of Medical Education and Research, Chandigarh; St Johns Medical College Hospital, Bangalore, India; St. John's Medical College, Bangalore; Wellcome Trust
• Treatments: Beractant; Goat lung surfactant extract; Pulmonary Surfactants

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 ≤32 completed weeks

2. Onset of respiratory distress within six hours of age

3. If baby meets criteria for surfactant replacement therapy:

1. FiO2 needed is 40% or higher while the baby is on CPAP to maintain pre-ductal oxygen saturation between 90% to 95% or

2. Baby needs intubation because of CPAP failure or severe respiratory distress (Chest X-ray is not mandatory for deciding the need for SRT). Detailed SOPs will be developed with respect to assessing the eligibility 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