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.
Najafian, Bita; Karimi-Sari, Hamidreza; Khosravi, Mohammad Hosseinet al.
2016 • In Contemporary clinical trials communications, 3, p. 55-59
Beractant; Complications; Poractant alfa; Respiratory distress syndrome; Treatment outcome; Pharmacology; General Medicine
Abstract :
[en] INTRODUCTION: The benefit of surfactant prescription for respiratory distress syndrome (RDS) has been approved. Curosurf and Survanta are two commonly used natural surfactants in Iran. Previous studies did not report priority for one of these two drugs. The present study aimed to compare the effectiveness and safety of Curosurf and Survanta in treatment of RDS.
METHODS: In this randomized clinical trial, neonates were born with RDS diagnosis in two governmental and referral hospitals of Tehran (the capital of Iran) in 2014 were randomly selected. Neonates were randomly assigned into two groups receiving 100 mg/kg Curosurf or Survanta as soon as possible after randomization. Complications, mortality and needing the second dose were compared between the two groups.
RESULTS: A total 112 patients with the mean gestational age of 32.59 ± 3.39 weeks were evaluated (56 patients in each group). There were no significant differences regarding birth weight, gestational age, delivery method, and parity between the two groups (P > 0.05). The complications were occurred in 18 neonates (32.1%) of Curosurf group and 20 neonates (35.7%) of Survanta group (RR = 0.922, 95% CI = 0.617-1.379). There were no significant differences regarding complications, mortality, and needing nasal CPAP and endotracheal tube between the two groups. In the neonates with gestational age of 29-32 weeks the IVH and NEC incidence were significantly more in Curosurf group compared to Survanta group (27.8% vs 0% and 22.3% vs 0%, P < 0.05).
CONCLUSION: There was no significant difference in complications or mortality between those two groups; however Curosurf was associated with less need of ET tube (in >32 birth weeks subgroup) and NCPAP (in 29-32 birth weeks subgroup) (p = 0.008). Further evaluations with longer follow-up duration are needed for comparing these two surfactants.
Disciplines :
Pediatrics
Author, co-author :
Najafian, Bita; Department of Pediatrics, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran
Karimi-Sari, Hamidreza; Students' Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, Iran
Khosravi, Mohammad Hossein ; Université de Liège - ULiège ; Students' Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, Iran
Nikjoo, Niloofar; Medical Student Research Committee (MSRC), Iran University of Medical Sciences, Tehran, Iran
Amin, Sobhan; Department of Pediatrics, Faculty of Medicine, Baqiyatallah University of Medical Sciences, Tehran, Iran
Shohrati, Majid; Chemical Injury Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran
Language :
English
Title :
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.
S. Hintz, W. Poole, L. Wright, A. Fanaroff, D. Kendrick, A. Laptook, and et al. Changes in mortality and morbidities among infants born at less than 25 weeks during the post-surfactant era Archives Dis. Childhood-Fetal Neonatal Ed. 90 2 2005 F128 F133
O. Helve, O. Pitkänen, C. Janér, and S. Andersson Pulmonary fluid balance in the human newborn infant Neonatology 95 4 2009 347 352
M. Somaschini, L.M. Nogee, I. Sassi, O. Danhaive, S. Presi, R. Boldrini, and et al. Unexplained neonatal respiratory distress due to congenital surfactant deficiency J. Pediatr. 150 6 2007 649 653
J.A. Whitsett The molecular era of surfactant biology Neonatology 105 4 2014 337 343
G.K. Suresh, and R.F. Soll Overview of surfactant replacement trials J. Perinatology 25 2005 S40 S44
D.J. Henderson-Smart, A. Wilkinson, and C.H. Raynes-Greenow Mechanical ventilation for newborn infants with respiratory failure due to pulmonary disease Cochrane Database Syst. Rev. 4 2002 (CD002770)
T.P. Stevens, E. Harrington, M. Blennow, and R. Soll Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome Cochrane Database Syst. Rev. 4 4 2007
H. Verder, B. Robertson, G. Greisen, F. Ebbesen, P. Albertsen, K. Lundstrom, and et al. Surfactant therapy and nasal continuous positive airway pressure for newborns with respiratory distress syndrome N. Engl. J. Med. 331 16 1994 1051 1055
B. Najafian, A. Saburi, S.H. Fakhraei, A. Afjeh, F. Eghbal, and R. Noroozian Predicting factors of INSURE failure in low birth-weight neonates with respiratory distress syndrome: a logistic regression model Iran. J. Neonatol. 5 4 2014 31
A. Cherif, C. Hachani, and N. Khrouf Risk factors of the failure of surfactant treatment by transient intubation during nasal continuous positive airway pressure in preterm infants Am. J. Perinatology 25 10 2008 647 652
C. Dani, I. Corsini, G. Bertini, G. Fontanelli, S. Pratesi, and F.F. Rubaltelli The INSURE method in preterm infants of less than 30 weeks' gestation J. Maternal-Fetal Neonatal Med. 23 9 2010 1024 1029
B.M. Casey, D.D. McIntire, and K.J. Leveno The continuing value of the Apgar score for the assessment of newborn infants N. Engl. J. Med. 344 7 2001 467 471
R. Ramanathan, M.R. Rasmussen, D.R. Gerstmann, N. Finer, K. Sekar, and N.A.S. 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. Perinatology 21 3 2004 109 119
E.A. Dizdar, F.N. Sari, C. Aydemir, S.S. Oguz, O. Erdeve, N. Uras, and et al. A randomized, controlled trial of poractant alfa versus beractant in the treatment of preterm infants with respiratory distress syndrome Am. J. Perinatology 29 2 2012 95 100
M.M. Gharehbaghi, S.H.P. Sakha, M. Ghojazadeh, and F. Firoozi Complications among premature neonates treated with beractant and poractant alfa Indian J. Pediatr. 77 7 2010 751 754
A. Fujii, S. Patel, R. Allen, G. Doros, C. Guo, and S. Testa Poractant alfa and beractant treatment of very premature infants with respiratory distress syndrome J. Perinatology 30 10 2010 665 670
Dilli D. Bozdaǧ Ş, T. Gökmen, and U. Dilmen Comparison of two natural surfactants for pulmonary hemorrhage in very low-birth-weight infants: a randomized controlled trial Am. J. Perinatology 32 3 2015 211 218
D. Terek, D. Gonulal, O.A. Koroglu, M. Yalaz, M. Akisu, and N. Kultursay 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. 56 4 2014 248 255
Z. Eras, E.A. Dizdar, G. Kanmaz, N. Guzoglu, H.T. Aksoy, G.B. Altunkaya, and et al. Neurodevelopmental outcomes of very low birth weight preterm infants treated with poractant alfa versus beractant for respiratory distress syndrome Am. J. Perinatology 31 6 2014 463 468
S. Paul, S. Rao, R. Kohan, J. McMichael, N. French, G. Zhang, and et al. Poractant alfa versus beractant for respiratory distress syndrome in preterm infants: a retrospective cohort study J. Paediatr. Child Health 49 10 2013 839 844
