A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol

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dc.contributor.authorLategan, Ilse
dc.contributor.authorDurand, David
dc.contributor.authorHarrison, Michael
dc.contributor.authorNakwa, Firdose
dc.contributor.authorVan Wyk, Lizelle
dc.contributor.authorVelaphi, Sithembiso
dc.contributor.authorHorn, Alan
dc.contributor.authorKali, Gugu
dc.contributor.authorSoll, Roger
dc.contributor.authorEhret, Danielle
dc.contributor.authorZar, Heather
dc.contributor.authorTooke, Lloyd
dc.date.accessioned2023-09-26T09:24:58Z
dc.date.available2023-09-26T09:24:58Z
dc.date.issued2023-09-19
dc.date.updated2023-09-24T03:12:32Z
dc.description.abstractIntroduction Respiratory distress syndrome in preterm infants is an important cause of morbidity and mortality. Less invasive methods of surfactant administration, along with the use of continuous positive airway pressure (CPAP), have improved outcomes of preterm infants. Aerosolized surfactant can be given without the need for airway instrumentation and may be employed in areas where these skills are scarce. Recent trials from high-resourced countries utilising aerosolized surfactant have had a low quality of evidence and varying outcomes. Methods and analysis The Neo-INSPIRe trial is an unblinded, multicentre, randomised trial of a novel aerosolized surfactant drug/device combination. Inclusion criteria include preterm infants of 27–34+6 weeks’ gestational age who weigh 900-1999g and who require CPAP with a fraction of inspired oxygen (FiO2) of 0.25–0.35 in the first 2–24 h of age. Infants are randomised 1:1 to control (CPAP alone) or intervention (CPAP with aerosolized surfactant). The primary outcome is the need for intratracheal bolus surfactant instillation within 72 h of age. Secondary outcomes include the incidence of reaching failure criteria (persistent FiO2 of > 0.40, severe apnoea or severe work of breathing), the need for and duration of ventilation and respiratory support, bronchopulmonary dysplasia and selected co-morbidities of prematurity. Assuming a 40% relative risk reduction to reduce the proportion of infants requiring intratracheal bolus surfactant from 45 to 27%, the study will aim to enrol 232 infants for the study to have a power of 80% to detect a significant difference with a type 1 error of 0.05. Ethics and dissemination Ethical approval has been granted by the relevant human research ethics committees at University of Cape Town (HREC 681/2022), University of the Witwatersrand HREC (221112) and Stellenbosch University (M23/02/004). Trial registration PACTR202307490670785
dc.identifier.apacitationLategan, I., Durand, D., Harrison, M., Nakwa, F., Van Wyk, L., Velaphi, S., ... Tooke, L. (2023). A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol. <i>BMC Pediatrics</i>, 23(1), 472. http://hdl.handle.net/11427/38842en_ZA
dc.identifier.chicagocitationLategan, Ilse, David Durand, Michael Harrison, Firdose Nakwa, Lizelle Van Wyk, Sithembiso Velaphi, Alan Horn, et al "A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol." <i>BMC Pediatrics</i> 23, 1. (2023): 472. http://hdl.handle.net/11427/38842en_ZA
dc.identifier.citationLategan, I., Durand, D., Harrison, M., Nakwa, F., Van Wyk, L., Velaphi, S., Horn, A. & Kali, G. et al. 2023. A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol. <i>BMC Pediatrics.</i> 23(1):472. http://hdl.handle.net/11427/38842en_ZA
dc.identifier.ris TY - Journal Article AU - Lategan, Ilse AU - Durand, David AU - Harrison, Michael AU - Nakwa, Firdose AU - Van Wyk, Lizelle AU - Velaphi, Sithembiso AU - Horn, Alan AU - Kali, Gugu AU - Soll, Roger AU - Ehret, Danielle AU - Zar, Heather AU - Tooke, Lloyd AB - Introduction Respiratory distress syndrome in preterm infants is an important cause of morbidity and mortality. Less invasive methods of surfactant administration, along with the use of continuous positive airway pressure (CPAP), have improved outcomes of preterm infants. Aerosolized surfactant can be given without the need for airway instrumentation and may be employed in areas where these skills are scarce. Recent trials from high-resourced countries utilising aerosolized surfactant have had a low quality of evidence and varying outcomes. Methods and analysis The Neo-INSPIRe trial is an unblinded, multicentre, randomised trial of a novel aerosolized surfactant drug/device combination. Inclusion criteria include preterm infants of 27–34+6 weeks’ gestational age who weigh 900-1999g and who require CPAP with a fraction of inspired oxygen (FiO2) of 0.25–0.35 in the first 2–24 h of age. Infants are randomised 1:1 to control (CPAP alone) or intervention (CPAP with aerosolized surfactant). The primary outcome is the need for intratracheal bolus surfactant instillation within 72 h of age. Secondary outcomes include the incidence of reaching failure criteria (persistent FiO2 of > 0.40, severe apnoea or severe work of breathing), the need for and duration of ventilation and respiratory support, bronchopulmonary dysplasia and selected co-morbidities of prematurity. Assuming a 40% relative risk reduction to reduce the proportion of infants requiring intratracheal bolus surfactant from 45 to 27%, the study will aim to enrol 232 infants for the study to have a power of 80% to detect a significant difference with a type 1 error of 0.05. Ethics and dissemination Ethical approval has been granted by the relevant human research ethics committees at University of Cape Town (HREC 681/2022), University of the Witwatersrand HREC (221112) and Stellenbosch University (M23/02/004). Trial registration PACTR202307490670785 DA - 2023-09-19 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - BMC Pediatrics KW - Surfactant KW - Aerosolized KW - Nebulized KW - Preterm KW - Neonatal KW - RDS LK - https://open.uct.ac.za PY - 2023 T1 - A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol TI - A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol UR - http://hdl.handle.net/11427/38842 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12887-023-04296-4
dc.identifier.urihttp://hdl.handle.net/11427/38842
dc.identifier.vancouvercitationLategan I, Durand D, Harrison M, Nakwa F, Van Wyk L, Velaphi S, et al. A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol. BMC Pediatrics. 2023;23(1):472. http://hdl.handle.net/11427/38842.en_ZA
dc.language.rfc3066en
dc.publisherBioMed Central
dc.publisher.departmentPaediatrics and Child Health
dc.publisher.facultyHealth Sciences
dc.rights.holderBioMed Central Ltd., part of Springer Nature
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceBMC Pediatrics
dc.source.journalissue1
dc.source.journalvolume23
dc.source.pagination472
dc.source.urihttps://bmcpediatr.biomedcentral.com/
dc.subjectSurfactant
dc.subjectAerosolized
dc.subjectNebulized
dc.subjectPreterm
dc.subjectNeonatal
dc.subjectRDS
dc.titleA multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
dc.typeJournal Article
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