Cresi Francesco, Maggiora Elena, Borgione Silvia Maria, Spada Elena, Coscia Alessandra, Bertino Enrico, Meneghin Fabio, Corvaglia Luigi Tommaso, Ventura Maria Luisa, Lista Gianluca
Neonatal Pathology and Neonatal Intensive Care Unit, Università di Torino, Turin, Italy.
Neonatal Pathology and Neonatal Intensive Care Unit, Vittore-Buzzi Children Hospital, Milan, Italy.
Trials. 2019 Jan 18;20(1):67. doi: 10.1186/s13063-018-3119-0.
Respiratory distress syndrome (RDS) and feeding intolerance are common conditions in preterm infants and among the major causes of neonatal mortality and morbidity. For many years, preterm infants with RDS have been treated with mechanical ventilation, increasing risks of acute lung injury and bronchopulmonary dysplasia. In recent years non-invasive ventilation techniques have been developed. Showing similar efficacy and risk of bronchopulmonary dysplasia, nasal continuous positive airway pressure (NCPAP) and heated humidified high-flow nasal cannula (HHHFNC) have become the most widespread techniques in neonatal intensive care units. However, their impact on nutrition, particularly on feeding tolerance and risk of complications, is still unknown in preterm infants. The aim of the study is to evaluate the impact of NCPAP vs HHHFNC on enteral feeding and to identify the most suitable technique for preterm infants with RDS.
A multicenter randomized single-blind controlled trial was designed. All preterm infants with a gestational age of 25-29 weeks treated with NCPAP or HHHFNC for RDS and demonstrating stability for at least 48 h along with the compliance with inclusion criteria (age less than 7 days, need for non-invasive respiratory support, suitability to start enteral feeding) will be enrolled in the study and randomized to the NCPAP or HHHFNC arm. All patients will be monitored until discharge, and data will be analyzed according to an intention-to-treat model. The primary outcome is the time to reach full enteral feeding, while parameters of respiratory support, feeding tolerance, and overall health status will be evaluated as secondary outcomes. The sample size was calculated at 141 patients per arm.
The identification of the most suitable technique (NCPAP vs HHHFNC) for preterm infants with feeding intolerance could reduce gastrointestinal complications, improve growth, and reduce hospital length of stay, thus improving clinical outcomes and reducing health costs. The evaluation of the timing of oral feeding could be useful in understanding the influence that these techniques could have on the development of sucking-swallow coordination. Moreover, the evaluation of the response to NCPAP and HHHFNC could clarify their efficacy as a treatment for RDS in extremely preterm infants.
ClinicalTrials.gov, NCT03548324 . Registered on 7 June 2018.
呼吸窘迫综合征（RDS）和喂养不耐受是早产儿常见的病症，也是新生儿死亡和发病的主要原因。多年来，患有RDS的早产儿一直采用机械通气治疗，这增加了急性肺损伤和支气管肺发育不良的风险。近年来，无创通气技术得到了发展。鼻持续气道正压通气（NCPAP）和温热湿化高流量鼻导管（HHHFNC）显示出相似的疗效和支气管肺发育不良风险，已成为新生儿重症监护病房中应用最广泛的技术。然而，它们对营养的影响，尤其是对喂养耐受性和并发症风险的影响，在早产儿中仍不清楚。本研究的目的是评估NCPAP与HHHFNC对肠内喂养的影响，并确定最适合患有RDS的早产儿的技术。
设计了一项多中心随机单盲对照试验。所有胎龄为25 - 29周、因RDS接受NCPAP或HHHFNC治疗且至少稳定48小时并符合纳入标准（年龄小于7天、需要无创呼吸支持、适合开始肠内喂养）的早产儿将被纳入研究，并随机分为NCPAP组或HHHFNC组。所有患者将被监测至出院，数据将根据意向性分析模型进行分析。主要结局是达到完全肠内喂养的时间，而呼吸支持参数、喂养耐受性和整体健康状况将作为次要结局进行评估。每组的样本量计算为141例患者。
确定最适合喂养不耐受早产儿的技术（NCPAP与HHHFNC）可以减少胃肠道并发症，改善生长发育，并缩短住院时间，从而改善临床结局并降低医疗成本。评估经口喂养的时机可能有助于了解这些技术对吸吮 - 吞咽协调发育的影响。此外，评估对NCPAP和HHHFNC的反应可以阐明它们作为极早产儿RDS治疗方法的疗效。
ClinicalTrials.gov，NCT03548324。于2018年6月7日注册。
