Exploration of the Impacts of Curosurf at 100 and 200 mg/kg Doses in Neonates with Respiratory Distress Syndrome

Document Type : Original Article

Authors

1 Department of Pediatrics and Neonates, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran

2 Department of Community Medicine, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran

Abstract

Background: The use of surfactants is still considered a cornerstone in the treatment of neonatal respiratory distress syndrome (RDS). This study aimed to compare two doses of Curosurf to determine the most effective dose of this medicine with the least side effects. The study was performed as a double-blind clinical trial in the Neonatal Intensive Care Unit of Valiasr Hospital in Birjand, Iran, from June to October 2021 on 51 neonates admitted with RDS.
Methods: Neonates with RDS who met the inclusion criteria were randomly divided into two groups. Initially, they underwent nasal Continuous Positive Air Way Pressure (n-CPAP), and if failed, Curosurf was administered intratracheally at a dose of 100 or 200 mg/kg. The two groups were compared in the mean hospital stay, the need for supplemental oxygen, the need for n-CPAP, the start of complementary feeding after Curosurf injection, the relative frequency of the need for mechanical ventilation, and possible complications after the injection and re-injection of surfactant. Data were analyzed using the independent sample t-test, the Mann–Whitney U test, Chi-squared test, and Fisher’s exact test at a significance level of α=0.05.
Results: The sample size was calculated based on the existing studies considering the days of the need for oxygen therapy in the two groups with different doses of surfactant (6.4±3.5 and 8.9±2.6 days) and according to the formula for comparing the means in the two groups with 95% confidence interval and 80% power. Accordingly, 24 neonates were assigned to each group. N=[z (1-α/2)+z (1-β)] (δ12+δ22)/ (µ1-µ2)2. Data were analyzed at a significant level of α=0.05. The findings indicated no significant difference between the two groups of neonates in the mean length of hospital stay, adjuvant oxygen requirement, n-CPAP requirement, time to oral feeding initiation from birth with breast milk (with breast or assistive devices) or formula, the relative frequency of the need for mechanical ventilation, and possible side effects after the injection and re-injection of surfactant.
Conclusion: In conclusion, 100 and 200 mg/kg of Curosurf appear to have the same effects and outcomes in the treatment of neonatal RDS.
 
 

Keywords

References

  1. Kliegman RM, ST Geme JW, Blum NJ, Shah SS, Tasker RC, Wilson KM. Textbook of Pediatrics. 21th ed. Philadelphia: Elsevier; 2020.
  2. Martin RJ, Fanaroff AA, Walsh MC. Fanaroff and Martin's neonatal-perinatal medicine diseases of the Fetus and Infant. 11th ed. Philadelphia: Elsevier; 2020.
  3. Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, et al. European consensus guidelines on the management of respiratory distress syndrome - 2019 Update. Neonatology. 2019; 115(4):432-50.
  4. Chao YC, Grobelna A. Curosurf (Poractant alfa) for the treatment of infants at risk for or experiencing respiratory distress syndrome: A review of clinical effectiveness, cost-effectiveness, and guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018.
  5. Mirzarahimi M, Barak M. Comparison efficacy of Curosurf and Survanta in preterm infants with respiratory distress syndrome. Pak J Pharm Sci. 2018; 31(2):469-472.
  6. 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(5):1-10.
  7. Najafian B, Karimi-Sari H, Khosravi MH, 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):55-59.
  8. Şimşek GK, Kutman HGK, Canpolat FE, Oğuz SS. Effect of two different early rescue surfactant treatments on mortality in preterm infants with respiratory distress syndrome. Clin Respir J. 2019; 14(3):285-90.
  9. Herting E, Hartel C, Gopel W. Less invasive surfactant administration (LISA): Chances and limitations. BMJ. 2019; 104(6):655-659.
  10. Banerjee S, Fernandez R, Fox GF, Goss KCW, Mactier H, Reynolds P, et al. Surfactant replacement therapy for respiratory distress syndrome in preterm infants: United Kingdom National Consensus. Pediatr Res. 2019; 86:12-14.
  11. Wang N, Wang L. Pharmacoeconomic evaluation of different doses of Curosurf for treating neonatal acute respiratory distress syndrome. Pak J Pharm Sci. 2020; 33(3):1139-46.
  12. Singh N, Hawley KL, Viswanathan Efficacy of porcine versus bovine surfactants for preterm newborns with respiratory distress syndrome: systematic review and meta-analysis. Pediatrics. 2011; 128(6): 1588-95.
  13. Królak-Olejnik B, Hozejowski R, Szczapa T. Dose Effect of Poractant Alfa in Neonatal RDS: Analysis of Combined Data from Three Prospective Studies. Front Pediatr. 2020; 8:1-8.
  14. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar Kandthe, 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.
Iranian Journal of Neonatology
Volume 13, Issue 3
July 2022
Pages 15-20

Files

Share

How to cite

Statistics