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

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...

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Autores principales: Lategan, Ilse, Durand, David, Harrison, Michael, Nakwa, Firdose, Van Wyk, Lizelle, Velaphi, Sithembiso, Horn, Alan, Kali, Gugu, Soll, Roger, Ehret, Danielle, Zar, Heather, Tooke, Lloyd
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10507916/
https://www.ncbi.nlm.nih.gov/pubmed/37726758
http://dx.doi.org/10.1186/s12887-023-04296-4
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author Lategan, Ilse
Durand, David
Harrison, Michael
Nakwa, Firdose
Van Wyk, Lizelle
Velaphi, Sithembiso
Horn, Alan
Kali, Gugu
Soll, Roger
Ehret, Danielle
Zar, Heather
Tooke, Lloyd
author_facet Lategan, Ilse
Durand, David
Harrison, Michael
Nakwa, Firdose
Van Wyk, Lizelle
Velaphi, Sithembiso
Horn, Alan
Kali, Gugu
Soll, Roger
Ehret, Danielle
Zar, Heather
Tooke, Lloyd
author_sort Lategan, Ilse
collection PubMed
description 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 (FiO(2)) 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-023-04296-4.
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spelling pubmed-105079162023-09-20 A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol Lategan, Ilse Durand, David Harrison, Michael Nakwa, Firdose Van Wyk, Lizelle Velaphi, Sithembiso Horn, Alan Kali, Gugu Soll, Roger Ehret, Danielle Zar, Heather Tooke, Lloyd BMC Pediatr Study Protocol 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 (FiO(2)) 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 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12887-023-04296-4. BioMed Central 2023-09-19 /pmc/articles/PMC10507916/ /pubmed/37726758 http://dx.doi.org/10.1186/s12887-023-04296-4 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Lategan, Ilse
Durand, David
Harrison, Michael
Nakwa, Firdose
Van Wyk, Lizelle
Velaphi, Sithembiso
Horn, Alan
Kali, Gugu
Soll, Roger
Ehret, Danielle
Zar, Heather
Tooke, Lloyd
A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
title A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
title_full A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
title_fullStr A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
title_full_unstemmed A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
title_short A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
title_sort multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: neo-inspire trial protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10507916/
https://www.ncbi.nlm.nih.gov/pubmed/37726758
http://dx.doi.org/10.1186/s12887-023-04296-4
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