Browsing by Subject "Surfactant"

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    A 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, Lloyd
    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
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    Diagnostic utility of lung ultrasound in preterm neonates with respiratory distress at a tertiary neonatal intensive care unit in the Western Cape
    (2025) Mpisane-Jama, Fefekazi; Horn, Alan
    Background: Accumulating data suggest the potential for lung ultrasound (LUS) to diagnose lung pathology and predict the need for surfactant administration in preterm babies, but there are no published data from South Africa. Objectives: The objectives were to describe LUS diagnoses and outcomes in preterm babies receiving non-invasive respiratory support in a South African neonatal unit, and to compare LUS with clinical diagnoses and surfactant administration. Methods: We conducted a prospective, observational study of babies 27–34 weeks' gestation, birth weight ≥ 800 grams, receiving non-invasive respiratory support who had LUS at age ≤ 3 hours. Surfactant was administered at fraction of inspired oxygen (FiO2) 0.35–0.45 and was not influenced by LUS findings. Results: Over a 4-month period, 51 babies were included – eight (16%) received surfactant, all of whom had respiratory distress syndrome (RDS) as their only clinical diagnosis, compared to overlapping diagnoses in the non-surfactant group; RDS (93%), TTN (16%) and pneumonia (14%). Lung ultrasound suggested less RDS in the non-surfactant group (42% vs. 88%; p=0.002), and more TTN (79% vs. 38%; p=0.002) and TTN plus pneumonia (65% vs. 25%; p=0.03). The LUS score (LUSS) predicted surfactant administration (Area under the curve 0.8 [95% confidence interval 67-94%]). A LUSS of 7 had the best combined sensitivity (75%) and specificity (72%) but low positive predictive value (33%). A LUSS of 8 identified 8/43 (19%) additional babies for surfactant who did not need treatment. Conclusion: Lung ultrasound suggested a higher frequency of alternative and additional diagnoses than clinical assessment but was not an adequate single indicator of surfactant requirement, compared to FiO2 threshold. The high frequency of LUS features of TTN in the non-surfactant group, highlights the need to consider TTN as an alternative diagnosis in similar preterm neonates.