Efficacy and Safety of Goat Lung Surfactant for the Treatment of Respiratory Distress Syndrome in Preterm Neonates
NCT02774044 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2016-05-17
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).
Conditions
- Respiratory Distress Syndrome
Interventions
- DRUG
-
Cadisurf
Cadisurf Intratracheal suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural lung extract containing phospholipids and surfactant-associated proteins. The resulting composition provides 25 mg/mL phospholipids and less than 1.0 mg/ml protein. It is suspended in 0.9% sodium chloride solution. Cadisurf contains no preservatives. Each ml of Cadisurf contains 25 mg of phospholipids. It is a creamy white suspension supplied in single-use glass vials containing 8 mL (200 mg phospholipids).
- DRUG
-
Survanta
Sponsors & Collaborators
-
Maulana Azad Medical College, New Delhi
collaborator UNKNOWN -
Lady Hardinge Medical College
collaborator OTHER_GOV -
Chacha Nehru Bal Chikitsalya, Delhi
collaborator UNKNOWN -
Post Graduate Institute of Medical Education and Research, Chandigarh
collaborator OTHER -
King Edward Memorial Hospital, Mumbai
collaborator OTHER_GOV -
Lokmanya Tilak Municipal General Hospital, Mumbai
collaborator UNKNOWN -
Institute of Child health and Hospital for Children, Chennai
collaborator UNKNOWN -
Jawaharlal Institute of Postgraduate Medical Education & Research
collaborator OTHER_GOV -
All India Institute of Medical Sciences
collaborator OTHER -
St Johns Medical College Hospital, Bangalore, India
collaborator OTHER -
King Edward Memorial Hospital, Pune
collaborator UNKNOWN -
Government Medical College, Chandigarh
collaborator OTHER -
Wellcome Trust
collaborator OTHER -
Ramesh K Agarwal
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 26 Weeks
- Max Age
- 32 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2019-02-28
- Completion
- 2019-05-31
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