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

Phase 2/3 Unknown 900 enrolled Ramesh K Agarwal All India Institute of Medical Sciences · collab Chacha Nehru Bal Chikitsalya, Delhi · collab Government Medical College, Chandigarh · collab Institute of Child health and Hospital for Children, Chennai · collab Jawaharlal Institute of Postgraduate Medical Education & Research · collab King Edward Memorial Hospital, Mumbai · collab King Edward Memorial Hospital, Pune · collab Lady Hardinge Medical College · collab Lokmanya Tilak Municipal General Hospital, Mumbai · collab Maulana Azad Medical College, New Delhi · collab Post Graduate Institute of Medical Education and Research, Chandigarh · collab St Johns Medical College Hospital, Bangalore, India · collab Wellcome Trust · collab

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2016-06
Primary completion: 2019-02
Completion: 2019-05

Outcome

Missed primary endpoint

paper There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) PMID 31485014 ↗

paper The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). PMID 31485014 ↗

Publications

Jain K, Nangia S, Ballambattu VB, Sundaram V, Sankar MJ, Ramji S, Vishnubhatla S, Thukral A, Gupta YK, Plakkal N, Sundaram M, Jajoo M, Kumar P, Jayaraman K, Jain A, Saili A, Murugesan A, Chawla D, Murki S, Nanavati R, Rao S, Vaidya U, Mehta A, Arora K, Mondkar J, Arya S, Bahl M, Utture A, Manerkar S, Bhat SR, Parikh T, Kumar M, Bajpai A, Sivanandan S, Dhawan PK, Vishwakarma G, Bangera S, Kumar S, Gopalakrishnan S, Jindal A, Natarajan CK, Saini A, Karunanidhi S, Malik M, Narang P, Kaur G, Yadav CP, Deorari A, Paul VK, Agarwal R. Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial. J Perinatol. 2019 Sep;39(Suppl 1):3-12. doi: 10.1038/s41372-019-0472-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Beractant	Other / unclassified	100 mg/kg	Other
Subject	Cadisurf	Unknown	100 mg/kg	Other