A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol
Abstract 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 surfac...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | BMC Pediatrics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12887-023-04296-4 |
| _version_ | 1797451474428493824 |
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| author | Ilse Lategan David Durand Michael Harrison Firdose Nakwa Lizelle Van Wyk Sithembiso Velaphi Alan Horn Gugu Kali Roger Soll Danielle Ehret Heather Zar Lloyd Tooke |
| author_facet | Ilse Lategan David Durand Michael Harrison Firdose Nakwa Lizelle Van Wyk Sithembiso Velaphi Alan Horn Gugu Kali Roger Soll Danielle Ehret Heather Zar Lloyd Tooke |
| author_sort | Ilse Lategan |
| collection | DOAJ |
| description | Abstract 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 |
| first_indexed | 2024-03-09T14:55:11Z |
| format | Article |
| id | doaj.art-62a04cd6690049c993801997b59ae608 |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-03-09T14:55:11Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-62a04cd6690049c993801997b59ae6082023-11-26T14:15:27ZengBMCBMC Pediatrics1471-24312023-09-0123111110.1186/s12887-023-04296-4A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocolIlse Lategan0David Durand1Michael Harrison2Firdose Nakwa3Lizelle Van Wyk4Sithembiso Velaphi5Alan Horn6Gugu Kali7Roger Soll8Danielle Ehret9Heather Zar10Lloyd Tooke11Department of Paediatrics and Child Health, University of Cape TownAerogen PharmaDepartment of Paediatrics and Child Health, University of Cape TownDepartment of Paediatrics and Child Health, University of the WitwatersrandDepartment of Paediatrics and Child Health, Stellenbosch UniversityDepartment of Paediatrics and Child Health, University of the WitwatersrandDepartment of Paediatrics and Child Health, University of Cape TownDepartment of Paediatrics and Child Health, Stellenbosch UniversityVermont Oxford NetworkVermont Oxford NetworkDepartment of Paediatrics and Child Health, University of Cape TownDepartment of Paediatrics and Child Health, University of Cape TownAbstract 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 PACTR202307490670785https://doi.org/10.1186/s12887-023-04296-4SurfactantAerosolizedNebulizedPretermNeonatalRDS |
| spellingShingle | Ilse Lategan David Durand Michael Harrison Firdose Nakwa Lizelle Van Wyk Sithembiso Velaphi Alan Horn Gugu Kali Roger Soll Danielle Ehret Heather Zar Lloyd Tooke A multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol BMC Pediatrics Surfactant Aerosolized Nebulized Preterm Neonatal RDS |
| 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 | Surfactant Aerosolized Nebulized Preterm Neonatal RDS |
| url | https://doi.org/10.1186/s12887-023-04296-4 |
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