Bovine surfactant in the treatment of pneumonia-induced–neonatal acute respiratory distress syndrome (NARDS) in neonates beyond 34 weeks of gestation: a multicentre, randomized, assessor-blinded, placebo-controlled trial
Tóm tắt
Neonatal acute respiratory distress syndrome (NARDS) reflects pulmonary surfactant dysfunction, and the usage of bovine surfactant (Calsurf) supplement may therefore be beneficial. To determine whether bovine surfactant given in NARDS can improve oxygenation and survival rate, we conducted a multicenter, randomized trial between January 2018 and June 2019, and we compared Calsurf treatment to controls in neonates with pneumonia accompanied by NARDS. Neonates who met the Montreux criteria definition of NARDS were included, and those with congenital heart and lung malformations were excluded. Primary outcomes were oxygenation index (OI) after Calsurf administration, and secondary outcomes were mortality, and duration of ventilator and oxygen between the two groups, and also other morbidities. Cumulatively, 328 neonates were recruited and analyzed, 162 in the control group, and 166 in the Calsurf group. The results shows that OI in the Calsurf group were significantly lower than that in the control group at 4 h (7.2 ± 2.7 and 11.4 ± 9.1, P = 0.001); similarly, OI in the Calsurf group were significantly lower than in the control group at 12 h ( 7.5 ± 3.1 and 11.2 ± 9.2, P = 0.001). Mortality and duration of ventilator support or oxygen use between the two groups were not significantly different. Conclusion: Calsurf acutely improved OI immediately after administration in pneumonia-induced NARDS; although, we observed no significant decrease in mortality, duration of ventilator or oxygen, or major morbidity.
Tài liệu tham khảo
Cheifetz IM. Pediatric ARDS. Respir Care 2017;62(6):718-731.
Phung TTB, Suzuki T, Phan PH (2017 Nov) Pathogen screening and prognostic factors in children with severe ARDS of pulmonary origin. Pediatr Pulmonol 52(11):1469–1477
Heidemann SM, Nair A, Bulut Y, Sapru A (2017) Pathophysiology and management of acute respiratory distress syndrome in children. Pediatr Clin N Am 64(5):1017–1037
De Luca D, van Kaam AH, Tingay DG (2017) The Montreux definition of neonatal ARDS: biological and clinical background behind the description of a new entity. Lancet Respir Med 5(8):657–666
Fenton TR, Nasser R, Eliasziw M, Kim JH, Bilan D, Sauve R (2013) Validating the weight gain of preterm infants between the reference growth curve of the fetus and the term infant. BMC Pediatr 13:92
Claireaux AE (1953) Hyaline membrane in the neonatal lung. Lancet 262:749–753
Luo J, Chen J, Li Q, Feng Z (2019) Differences in clinical characteristics and therapy of neonatal acute respiratory distress syndrome (ARDS) and respiratory distress syndrome (RDS): a retrospective analysis of 925 cases. Med Sci Monit 25:4992–4998
Khemani RG, Smith LS, Zimmerman JJ, Erickson S (2015) for the Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress yndrome: definition, incidence, and epidemiology: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med 16(5 suppl 1):S23–S40
Günther A, Ruppert C, Schmidt R, Markart P, Grimminger F, Walmrath D, Seeger W (2001) Surfactant alteration and replacement in acute respiratory distress syndrome. Respir Res 2:353–364
Touqui L, Arbibe L (1999) A role for phospholipase A2 in ARDS pathogenesis. Mol Med Today 5:244–249
Spragg RG, Lewis JF, Walmrath H-D et al (2004) Effect of recombinant surfactant protein C-based surfactant on the acute respiratory distress syndrome. N Engl J Med 351(9):884–92. 98
Taut FJH, Rippin G, Schenk P, Findlay G, Wurst W, Häfner D, Lewis JF, Seeger W, Günther A, Spragg RG (2008) A search for subgroups of patients with ARDS who may benefit from surfactant replacement therapy: a pooled analysis of five studies with recombinant surfactant protein-C surfactant (Venticute). Chest 134(4):724–732
Kong X, Cui Q, Hu Y, Huang W, Ju R, Li W, Wang R, Xia S, Yu J, Zhu T, Feng Z (2016) Bovine surfactant replacement therapy in neonates of less than 32 weeks’ gestation: a multicenter controlled trial of prophylaxis versus early treatment in China--a pilot study. Pediatr Neonatol 57(1):19–26
Liu J, Yang N, Liu Y (2014) High-risk factors of respiratory distress syndrome in term neonates: a retrospective case-control study. Balkan Med J 31(1):64–68
Cogo PE, Facco M, Simonato M, de Luca D, de Terlizi F, Rizzotti U, Verlato G, Bellagamba MP, Carnielli VP (2011) Pharmacokinetics and clinical predictors of surfactant redosing in respiratory distress syndrome. Intensive Care Med 37(3):510–517
Singh N, Halliday HL, Stevens TP, Suresh G, Soll R, Rojas-Reyes MX (2015) Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev (12):CD010249. Published 2015 Dec 21. https://doi.org/10.1002/14651858.CD010249
Tridente A, De Martino L, De Luca D (2019) Porcine vs bovine surfactant therapy for preterm neonates with RDS: systematic review with biological plausibility and pragmatic meta-analysis of respiratory outcomes. Respir Res 20(1):28. Published 2019 Feb 6. https://doi.org/10.1186/s12931-019-0979-0
Liu J et al (2014) Clinical evaluation of Calsurf in treating full-term neonatal respiratory distress syndrome. Chin Pediatr Emerg Med 21(5):259–262
Wang XH et al (2014) Different dosage of bovine surfactant in treating respiratory distress syndrome in late preterm infants. Chin J Neonatol 29(1):43–45
Willson DF, Thomas NJ, Markovitz BP et al (2005) Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 293(4):470–476
Möller JC, Schaible T, Roll C et al (2003) Treatment with bovine surfactant in severe acute respiratory distress syndrome in children: a randomized multicenter study. Intensive Care Med 29(3):437–446
Rotta AT, Piva JP, Andreolio C et al (2015) Progress and perspectives in pediatric acute respiratory distress syndrome. Rev Bras Ter Intensiva 27(3):266–273
Wong JJ, Phan HP, Phumeetham S et al (2017) Risk stratification in pediatric acute respiratory distress syndrome: a multicenter observational study. Crit Care Med 45(11):1820–1828
Dell'Orto V, Bourgeois-Nicolaos N, Rouard C et al (2018) Cell count analysis from nonbronchoscopic bronchoalveolar lavage in preterm infants. J Pediatr 200:30–37.e2. https://doi.org/10.1016/j.jpeds.2018.04.074