Department of Paediatrics and Child Health, University of Cape Town, Cape Town, South Africa.
Aerogen Pharma, San Mateo, CA, USA.
BMC Pediatr. 2023 Sep 19;23(1):472. doi: 10.1186/s12887-023-04296-4.
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.
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 weeks' gestational age who weigh 900-1999g and who require CPAP with a fraction of inspired oxygen (FiO) 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.
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).
PACTR202307490670785.
早产儿呼吸窘迫综合征是发病率和死亡率的重要原因。使用较少侵入性的表面活性剂给药方法和持续气道正压通气（CPAP）可以改善早产儿的预后。雾化表面活性剂可以在不需要气道器械的情况下给予，并且可以在这些技能稀缺的地区使用。来自高资源国家的最近试验利用雾化表面活性剂的证据质量较低，结果也各不相同。
Neo-INSPIRe 试验是一项针对新型雾化表面活性剂药物/装置组合的非盲、多中心、随机试验。纳入标准包括胎龄 27-34 周、体重 900-1999g 的早产儿，出生后 2-24 小时内需要 CPAP，吸入氧分数（FiO2）为 0.25-0.35。婴儿以 1:1 的比例随机分为对照组（单独 CPAP）或干预组（CPAP 联合雾化表面活性剂）。主要结局是出生后 72 小时内需要经气管内推注表面活性剂。次要结局包括达到失败标准（持续 FiO2>0.40、严重呼吸暂停或严重呼吸做功）、需要和持续通气和呼吸支持、支气管肺发育不良以及早产儿的选定合并症的发生率。假设相对风险降低 40%，将需要经气管内推注表面活性剂的婴儿比例从 45%降低到 27%，该研究将招募 232 名婴儿，研究的效力为 80%，以检测出具有 0.05 一类错误的显著差异。
开普敦大学（HREC 681/2022）、威特沃特斯兰德大学 HREC（221112）和斯特伦博斯大学（M23/02/004）的相关人类研究伦理委员会已批准该研究。
PACTR202307490670785。
