Medium vs Low Oxygen Threshold for the Surfactant Administration

Summary

The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.

Timeline

Start

2021-06-01

Primary completion

2024-07-01

Completion

2025-04-30

Publications

• Background Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
• Background Engle WA; American Academy of Pediatrics Committee on Fetus and Newborn. Surfactant-replacement therapy for respiratory distress in the preterm and term neonate. Pediatrics. 2008 Feb;121(2):419-32. doi: 10.1542/peds.2007-3283.
• Background Jobe AH. Pulmonary surfactant therapy. N Engl J Med. 1993 Mar 25;328(12):861-8. doi: 10.1056/NEJM199303253281208. No abstract available.
• Background Ammari A, Suri M, Milisavljevic V, Sahni R, Bateman D, Sanocka U, Ruzal-Shapiro C, Wung JT, Polin RA. Variables associated with the early failure of nasal CPAP in very low birth weight infants. J Pediatr. 2005 Sep;147(3):341-7. doi: 10.1016/j.jpeds.2005.04.062.
• Background Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Predictors of early nasal CPAP failure and effects of various intubation criteria on the rate of mechanical ventilation in preterm infants of <29 weeks gestational age. Arch Dis Child Fetal Neonatal Ed. 2011 Sep;96(5):F343-7. doi: 10.1136/adc.2010.205898. Epub 2011 Jan 30.
• Background Dargaville PA, Gerber A, Johansson S, De Paoli AG, Kamlin CO, Orsini F, Davis PG; Australian and New Zealand Neonatal Network. Incidence and Outcome of CPAP Failure in Preterm Infants. Pediatrics. 2016 Jul;138(1):e20153985. doi: 10.1542/peds.2015-3985.
• Background Pillai MS, Sankar MJ, Mani K, Agarwal R, Paul VK, Deorari AK. Clinical prediction score for nasal CPAP failure in pre-term VLBW neonates with early onset respiratory distress. J Trop Pediatr. 2011 Aug;57(4):274-9. doi: 10.1093/tropej/fmq047. Epub 2010 Jun 16.
• Background Dargaville PA, Aiyappan A, De Paoli AG, Dalton RG, Kuschel CA, Kamlin CO, Orsini F, Carlin JB, Davis PG. Continuous positive airway pressure failure in preterm infants: incidence, predictors and consequences. Neonatology. 2013;104(1):8-14. doi: 10.1159/000346460. Epub 2013 Apr 4.
• Background De Jaegere AP, van der Lee JH, Cante C, van Kaam AH. Early prediction of nasal continuous positive airway pressure failure in preterm infants less than 30 weeks gestation. Acta Paediatr. 2012 Apr;101(4):374-9. doi: 10.1111/j.1651-2227.2011.02558.x. Epub 2012 Jan 9.
• Background Rocha G, Flor-de-Lima F, Proenca E, Carvalho C, Quintas C, Martins T, Freitas A, Paz-Dias C, Silva A, Guimaraes H. Failure of early nasal continuous positive airway pressure in preterm infants of 26 to 30 weeks gestation. J Perinatol. 2013 Apr;33(4):297-301. doi: 10.1038/jp.2012.110. Epub 2012 Aug 30.
• Background Gulczynska E, Szczapa T, Hozejowski R, Borszewska-Kornacka MK, Rutkowska M. Fraction of Inspired Oxygen as a Predictor of CPAP Failure in Preterm Infants with Respiratory Distress Syndrome: A Prospective Multicenter Study. Neonatology. 2019;116(2):171-178. doi: 10.1159/000499674. Epub 2019 May 21.
• Background Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21.
• Background Walsh BK, Daigle B, DiBlasi RM, Restrepo RD; American Association for Respiratory Care. AARC Clinical Practice Guideline. Surfactant replacement therapy: 2013. Respir Care. 2013 Feb;58(2):367-75. doi: 10.4187/respcare.02189.
• Background McCord FB, Curstedt T, Halliday HL, McClure G, Reid MM, Robertson B. Surfactant treatment and incidence of intraventricular haemorrhage in severe respiratory distress syndrome. Arch Dis Child. 1988 Jan;63(1):10-6. doi: 10.1136/adc.63.1.10.
• Background Narendran V, Donovan EF, Hoath SB, Akinbi HT, Steichen JJ, Jobe AH. Early bubble CPAP and outcomes in ELBW preterm infants. J Perinatol. 2003 Apr-May;23(3):195-9. doi: 10.1038/sj.jp.7210904.
• Background Hedstrom AB, Gove NE, Mayock DE, Batra M. Performance of the Silverman Andersen Respiratory Severity Score in predicting PCO2 and respiratory support in newborns: a prospective cohort study. J Perinatol. 2018 May;38(5):505-511. doi: 10.1038/s41372-018-0049-3. Epub 2018 Feb 9.
• Background Pang H, Zhang B, Shi J, Zang J, Qiu L. Diagnostic value of lung ultrasound in evaluating the severity of neonatal respiratory distress syndrome. Eur J Radiol. 2019 Jul;116:186-191. doi: 10.1016/j.ejrad.2019.05.004. Epub 2019 May 7.
• Background Li L, Yang Q, Li L, Guan J, Liu Z, Han J, Chao Y, Wang Z, Yu X. [The value of lung ultrasound score on evaluating clinical severity and prognosis in patients with acute respiratory distress syndrome]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2015 Jul;27(7):579-84. doi: 10.3760/cma.j.issn.2095-4352.2015.07.008. Chinese.
• Background Trachsel D, McCrindle BW, Nakagawa S, Bohn D. Oxygenation index predicts outcome in children with acute hypoxemic respiratory failure. Am J Respir Crit Care Med. 2005 Jul 15;172(2):206-11. doi: 10.1164/rccm.200405-625OC. Epub 2005 Apr 7.

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Indications