Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial. 2019

Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
All India Institute of Medical Sciences (AIIMS), New Delhi, India.

To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). 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). Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D007234 Infant, Premature A human infant born before 37 weeks of GESTATION. Neonatal Prematurity,Premature Infants,Preterm Infants,Infant, Preterm,Infants, Premature,Infants, Preterm,Premature Infant,Prematurity, Neonatal,Preterm Infant
D008297 Male Males
D010100 Oxygen An element with atomic symbol O, atomic number 8, and atomic weight [15.99903; 15.99977]. It is the most abundant element on earth and essential for respiration. Dioxygen,Oxygen-16,Oxygen 16
D011663 Pulmonary Surfactants Substances and drugs that lower the SURFACE TENSION of the mucoid layer lining the PULMONARY ALVEOLI. Surfactants, Pulmonary,Pulmonary Surfactant,Surfactant, Pulmonary
D012127 Respiratory Distress Syndrome, Newborn A condition of the newborn marked by DYSPNEA with CYANOSIS, heralded by such prodromal signs as dilatation of the alae nasi, expiratory grunt, and retraction of the suprasternal notch or costal margins, mostly frequently occurring in premature infants, children of diabetic mothers, and infants delivered by cesarean section, and sometimes with no apparent predisposing cause. Infantile Respiratory Distress Syndrome,Neonatal Respiratory Distress Syndrome,Respiratory Distress Syndrome, Infant
D002417 Cattle Domesticated bovine animals of the genus Bos, usually kept on a farm or ranch and used for the production of meat or dairy products or for heavy labor. Beef Cow,Bos grunniens,Bos indicus,Bos indicus Cattle,Bos taurus,Cow,Cow, Domestic,Dairy Cow,Holstein Cow,Indicine Cattle,Taurine Cattle,Taurus Cattle,Yak,Zebu,Beef Cows,Bos indicus Cattles,Cattle, Bos indicus,Cattle, Indicine,Cattle, Taurine,Cattle, Taurus,Cattles, Bos indicus,Cattles, Indicine,Cattles, Taurine,Cattles, Taurus,Cow, Beef,Cow, Dairy,Cow, Holstein,Cows,Dairy Cows,Domestic Cow,Domestic Cows,Indicine Cattles,Taurine Cattles,Taurus Cattles,Yaks,Zebus
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006041 Goats Any of numerous agile, hollow-horned RUMINANTS of the genus Capra, in the family Bovidae, closely related to the SHEEP. Capra,Capras,Goat

Related Publications

Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
January 2022, BMC pediatrics,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
January 1994, Jornal de pediatria,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
September 1991, American journal of diseases of children (1960),
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
September 2015, Scientific reports,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
July 2008, Pediatrics,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
June 2004, The Journal of pediatrics,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
January 2022, Archives of disease in childhood. Fetal and neonatal edition,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
February 2001, Pediatric radiology,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
June 1985, The Journal of pediatrics,
Kajal Jain, and Sushma Nangia, and Vishnu Bhat Ballambattu, and Venkataseshan Sundaram, and M Jeeva Sankar, and Siddharth Ramji, and Sreenivas Vishnubhatla, and Anu Thukral, and Yogendra Kumar Gupta, and Nishad Plakkal, and Mangalabharathi Sundaram, and Mamta Jajoo, and Praveen Kumar, and Kumutha Jayaraman, and Ashish Jain, and Arvind Saili, and Anitha Murugesan, and Deepak Chawla, and Srinivas Murki, and Ruchi Nanavati, and Suman Rao, and Umesh Vaidya, and Ashish Mehta, and Kamal Arora, and Jayashree Mondkar, and Sugandha Arya, and Monika Bahl, and Alpana Utture, and Swati Manerkar, and Swarna Rekha Bhat, and Tushar Parikh, and Manish Kumar, and Anurag Bajpai, and Sindhu Sivanandan, and Pawandeep Kaur Dhawan, and Gayatri Vishwakarma, and Sudhakar Bangera, and Sumit Kumar, and Shridhar Gopalakrishnan, and Atul Jindal, and Chandra Kumar Natarajan, and Anumeet Saini, and Sukanya Karunanidhi, and Meenakshi Malik, and Parul Narang, and Gurkirat Kaur, and Chander Prakash Yadav, and Ashok Deorari, and Vinod K Paul, and Ramesh Agarwal
January 2014, Pediatrics,
Copied contents to your clipboard!