Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials

Abstract

Findings from previous meta-analyses of randomized clinical trials (RCTs) in premature infants with respiratory distress syndrome (RDS) varied as to whether clinical outcomes differed by type of animal-derived pulmonary surfactant; real-world evidence (RWE) was excluded. We extracted study characteristics and outcomes from full-text articles from a systematic search for studies that compared beractant with poractant alfa for RDS in preterm infants. RWE data were tabulated; RCT data were subjected to meta-analyses. Designs, patient characteristics, and follow-up durations varied widely among studies (4 RWE, 15 RCT). RWE studies with adjusted odds ratios (ORs) found no statistically significant between-treatment differences in outcomes. In RCT meta-analyses, no statistically significant between-treatment differences were observed for death [OR (95% confidence interval) 1.35 (0.98-1.86)], bronchopulmonary dysplasia [1.25 (0.96-1.62)], pneumothorax [1.21 (0.72-2.05)], and air leak syndrome [2.28 (0.82-6.39)]. Collectively, outcomes were similar with beractant and poractant alfa in RWE studies and pooled RCTs.

Sanchez Luna M., Bacher P., Unnebrink K., Martinez-Tristani M., Ramos Navarro C. Beractant and poractant alfa in premature neonates with respiratory distress syndrome: a systematic review of real-world evidence studies and randomized controlled trials. J Perinatol. 2020. DOI: 10.1038/s41372-020-0603-7

References

1. Sweet D.G., Carnielli V., Greisen G., Hallman M., Ozek E., Plavka R., et al. European consensus guidelines on the management of respiratory distress syndrome - 2016 update. Neonatology. 2017; 111: 107-25.

2. Gallacher D.J., Hart K., Kotecha S. Common respiratory conditions of the newborn. Breathe (Sheff). 2016; 12: 30-42.

3. Polin R.A., Carlo W.A., Committee on Fetus and Newborn, American Academy of Pediatrics. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014; 133: 156-63.

4. Taylor G., Jackson W., Hornik C.P., Koss A., Mantena S., Homsley K., et al. Surfactant administration in preterm infants: drug development opportunities. J Pediatr. 2019; 208: 163-8.

5. Survanta (beractant). Full prescribing information. North Chicago, IL: AbbVie Inc.; 2012.

6. Curosurf (poractant alfa). Full prescribing information. Parma, Italy: Chiesi Farmaceutici, S.p.A.; 2014.

7. Survanta (beractant). Summary of product characteristics. Maidenhead, UK: AbbVie Ltd.; 2015.

8. Curosurf (poractant). Summary of product characteristics. Manchester, UK: Chiesi Limited; 2018.

9. Singh N., Halliday H.L., Stevens T.P., Suresh G., Soll R., Rojas-Reyes M.X. Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2015; 21: CD010249.

10. Zhang L., Cao H.Y., Zhao S., Yuan L.J., Han D., Jiang H., et al. Effect of exogenous pulmonary surfactants on mortality rate in neonatal respiratory distress syndrome: a network meta-analysis of randomized controlled trials. Pulm Pharmacol Ther. 2015; 34: 46-54.

11. Sherman R.E., Anderson S.A., Dal Pan G.J., Gray G.W., Gross T., Hunter N.L., et al. Real-world evidence-what is it and what can it tell us? N Engl J Med. 2016; 375: 2293-7.

12. US Food and Drug Administration. Framework for FDA’s real- world evidence program. Silver Spring, MD: US Food and Drug Administration; 2018.

13. Guyatt G., Oxman A.D., Akl E.A., Kunz R., Vist G., Brozek J., et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011; 64: 383-94.

14. National Collaborating Centre for Mental Health. Drug misuse: psychosocial interventions. NICE Clinical Practice Guidelines No. 51. Leicester, UK: The British Psychological Society & The Royal; 2008.

15. Trembath A., Hornik C.P., Clark R., Smith P.B., Daniels J., Laughon M., et al. Comparative effectiveness of surfactant preparations in premature infants. J Pediatr. 2013; 163: 955-60. e951.

16. Ramanathan R., Bhatia J.J., Sekar K., Ernst F.R. Mortality in preterm infants with respiratory distress syndrome treated with poractant alfa, cal-factant or beractant: a retrospective study. J Perinatol. 2013; 33: 119-25.

17. Paul S., Rao S., Kohan R., McMichael J., French N., Zhang G., et al. Poractant alfa versus beractant for respiratory distress syndrome in preterm infants: a retrospective cohort study. J Paediatr Child Health. 2013; 49: 839-44.

18. Naseh A., Yekta B.G.. INSURE method (INtubation-SURfactant-Extubation) in early and late premature neonates with respiratory distress: factors affecting the outcome and survival rate. Turk J Pediatr. 2014; 56: 232-7.

19. Ramanathan R., Rasmussen M.R., Gerstmann D.R., Finer N., Sekar K., North American Study Group. A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol. 2004; 21: 109-19.

20. Eras Z., Dizdar E.A., Kanmaz G., Guzoglu N., Aksoy H.T., Altun-kaya G.B., et al. Neurodevelopmental outcomes of very low birth weight preterm infants treated with poractant alfa versus beractant for respiratory distress syndrome. Am J Perinatol. 2014; 31: 463-8.

21. Fujii A.M., Patel S.M., Allen R., Doros G., Guo C.Y., Testa S. Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome. J Perinatol. 2010; 30: 665-70.

22. Mussavi M., Mirnia K., Asadollahi K. Comparison of the efficacy of three natural surfactants (Curosurf, Survanta, and Alveofact) in the treatment of respiratory distress syndrome among neonates: a randomized controlled trial. Iran J Pediatr. 2016; 26: e5743.

23. Gharehbaghi M.M., Sakha S.H., Ghojazadeh M., Firoozi F. Complications among premature neonates treated with beractant and poractant alfa. Indian J Pediatr. 2010; 77: 751-4.

24. Mirzarahimi M., Barak M. Comparison efficacy of Curosurf and Survanta in preterm infants with respiratory distress syndrome. Pak J Pharm Sci. 2018; 31: 469-72.

25. Dizdar E.A., Sari F.N., Aydemir C., Oguz S.S., Erdeve O., Uras N., et al. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome. Am J Perinatol. 2012; 29: 95-100.

26. Najafian B., Karimi-Sari H., Khosravi M.H., Nikjoo N., Amin S., Shohrati M. Comparison of efficacy and safety of two available natural surfactants in Iran, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome: a randomized clinical trial. Contemp Clin Trials Commun. 2016; 3: 55-9.

27. Karadag N., Dilli D., Zenciroglu A., Aydin B., Beken S., Okumus N. Perfusion index variability in preterm infants treated with two different natural surfactants for respiratory distress syndrome. Am J Perinatol. 2014; 31: 1015-22.

28. Baroutis G., Kaleyias J., Liarou T., Papathoma E., Hatzistama-tiou Z., Costalos C. Comparison of three treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome. Eur J Pediatr. 2003; 162: 476-80.

29. Malloy C.A., Nicoski P., Muraskas J.K. A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome.Acta Paediatr. 2005; 94: 779-84.

30. Speer C.P., Gefeller O., Groneck P., Laufkotter E., Roll C., Hans-sler L., et al. Randomised clinical trial of two treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 1995; 72: F8-13.

31. Mercado V.V., Cristea I., Ali N., Pham C.C., Buescher E., Yang J., et al. Does surfactant type cause a differential proinflammatory response in preterm infants with respiratory distress syndrome? Adv Ther. 2010; 27: 476-82.

32. Saeidi R., Hamedi A., Javadi A., Gholami Robatsangi M., Dinparvar S.K. Comparison of side effect of Survanta and Curosurf in decreasing mortality due to respiratory distress syndrome (RDS) in premature infants admitted in NICU of Ghaem Hospital on 2006-2008. Iran J Neonatol. 2013; 4: 7-12.

33. Terek D., Gonulal D., Koroglu O.A., Yalaz M., Akisu M., Kultursay N. Effects of two different exogenous surfactant preparations on serial peripheral perfusion index and tissue carbon monoxide measurements in preterm infants with severe respiratory distress syndrome. Pediatr Neonatol. 2015; 56: 248-55.

34. Tridente A., De Martino L., De Luca D. Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes. Respir Res. 2019; 20: 28.

35. Halahakoon W.L. A study of cerebral function following surfactant treatment for respiratory distress syndrome. Doctoral dissertation. United Kingdom: Queen’s University of Belfast; 1999.

36. Jobe AH. Mechanisms to explain surfactant responses. Biol Neonate. 2006;89:298-302.

37. Dumpa V., Bhandari V. Surfactant, steroids and non-invasive ventilation in the prevention of BPD. Semin Perinatol. 2018; 42: 444-52.

38. Hartel C., Paul P., Hanke K., Humberg A., Kribs A., Mehler K., et al. Less invasive surfactant administration and complications of preterm birth. Sci Rep. 2018; 8: 8333.

39. Langhammer K., Roth B., Kribs A., Gopel W., Kuntz L., Miedaner F. Treatment and outcome data of very low birth weight infants treated with less invasive surfactant administration in comparison to intubation and mechanical ventilation in the clinical setting of a cross-sectional observational multicenter study. Eur J Pediatr. 2018; 177: 1207-17.

40. Brown S., Hurren J., Sartori H. Poractant alfa versus beractant for neonatal respiratory distress syndrome: a retrospective cost analysis. J Pediatr Pharm Ther. 2018; 23: 367-71.

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CHIEF EDITOR
CHIEF EDITOR
Degtyarev Dmitriy Nikolaevich
Doctor of Medical Sciences, Professor, Deputy Director for Scientific Research of the V.I. Kulakov Obstetrics, Gynecology and Perinatology National Medical Research Center of Ministry of Healthсаre of the Russian Federation, Head of the Chair of Neonatology at the Clinical Institute of Children's Health named after N.F. Filatov, I.M. Sechenov First Moscow State Medical University, Chairman of the Ethics Committee of the Russian Society of Neonatologists, Moscow, Russian Federation

ORCID iD 0000-0001-8975-2425

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