Browsing by Subject "RDS"
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- ItemOpen AccessA multicentre neonatal interventional randomised controlled trial of nebulized surfactant for preterm infants with respiratory distress: Neo-INSPIRe trial protocol(BioMed Central, 2023-09-19) Lategan, Ilse; Durand, David; Harrison, Michael; Nakwa, Firdose; Van Wyk, Lizelle; Velaphi, Sithembiso; Horn, Alan; Kali, Gugu; Soll, Roger; Ehret, Danielle; Zar, Heather; Tooke, LloydIntroduction 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
- ItemOpen AccessVulnerability and Adaptation to Climate Change in the Semi - Arid Regions of Southern Africa(2015-02-01) Spear, Dian; Haimbili, Emilia; Angula, Margaret; Baudoin, Marie - Ange; Hegga, Salma; Zaroug, Modathir; Okeyo, AliciaThe main objectives of the RDS phase are to i) develop a systematic understanding of existing knowledge and perceptions of climate change trends, impacts, vulnerability, adaptation strategies, and barriers and enablers to effective adaptation in SARs; ii) provide a system scale perspective from which ASSAR researchers can undertake research in the Regional Research Programme (RRP); and iii) help inform the more detailed sets of specific research foci for the RRP.