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Post-INSURE Administration of Heated Humidified High-Flow Therapy Versus Nasal Continuous Positive Airway Pressure in Preterm Infants More Than 28 Weeks Gestation with Respiratory Distress Syndrome: A Randomized Non-Inferiority Trial
Journal of Tropical Pediatrics ( IF 1.8 ) Pub Date : 2022-07-25 , DOI: 10.1093/tropej/fmac062
Srijan Singh 1 , Anitha Ananthan 1 , Ruchi Nanavati 1
Affiliation  

In preterm infants with respiratory distress syndrome (RDS), non-invasive ventilation (NIV) is usually provided using nasal continuous positive airway pressure (NCPAP) or non-invasive mechanical ventilation after surfactant administration by INtubation-SURfactant-Extubation (INSURE) method. Heated humidified high-flow nasal cannula (HHHFNC) is a mode of NIV with advantages of ease of application, less grades of nasal injury and easy handling. This study was done to compare the effectiveness of HHHFNC therapy administration as post-INSURE respiratory support in preterm infants as compared to NCPAP. The primary outcome was to compare the rate of treatment failure within 7 days of randomization to HHHFNC or NCPAP as a post-INSURE ventilatory modality. It was a pilot trial wherein all preterm infants more than 1 kg and more than 28 weeks gestational age with RDS who required surfactant were randomized to receive NCPAP or HHHFNC. Infants with an urgent need for intubation and mechanical ventilation were considered to have treatment failure. Thirty babies were enrolled—15 in each group. Baseline demographic characteristics were comparable. There was no significant difference in the primary outcome of early failure rate, i.e. mechanical ventilation rate within 7 days of starting treatment. There were no significant differences in other outcomes except nasal injury which was significantly lesser in the HHHFNC group. In conclusion, HHHFNC appears to be non-inferior to NCPAP when used in preterm infants more than 28 weeks gestation with RDS as a post-INSURE ventilatory modality.

中文翻译:

妊娠超过 28 周的呼吸窘迫综合征早产儿的加热加湿高流量治疗与鼻持续气道正压通气的 INSURE 后管理:一项随机非劣效性试验

对于患有呼吸窘迫综合征 (RDS) 的早产儿,通常在通过插管-表面活性剂-拔管 (INSURE) 方法施用表面活性剂后使用经鼻持续气道正压通气 (NCPAP) 或无创机械通气提供无创通气 (NIV)。加热湿化高流量鼻导管(HHHFNC)是一种NIV模式,具有应用方便、鼻损伤程度小、操作方便等优点。本研究旨在比较 HHHFNC 治疗作为早产儿 INSURE 后呼吸支持与 NCPAP 的有效性。主要结果是比较随机分配到 HHHFNC 或 NCPAP 作为 INSURE 后通气方式的 7 天内的治疗失败率。这是一项试点试验,其中所有需要表面活性剂的 RDS 超过 1 公斤和超过 28 周胎龄的早产儿被随机分配接受 NCPAP 或 HHHFNC。急需插管和机械通气的婴儿被认为治疗失败。招募了 30 名婴儿——每组 15 名。基线人口统计学特征具有可比性。早期失败率的主要结果,即开始治疗后 7 天内的机械通气率,没有显着差异。除了鼻部损伤在 HHHFNC 组中明显较小外,其他结果没有显着差异。总之,HHHFNC 在用于妊娠超过 28 周且 RDS 作为 INSURE 后通气方式的早产儿时,似乎不劣于 NCPAP。
更新日期:2022-07-25
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