Department of Acute Child Health, Children's Hospital for Wales, Cardiff, UK
Department of Paediatrics, Morriston Hospital, Swansea, UK.
BMJ Open. 2024 Nov 9;14(11):e087672. doi: 10.1136/bmjopen-2024-087672.
Ward-based high-flow nasal cannula (HFNC) is an effective therapy for children with bronchiolitis who have failed standard oxygen therapy. However, HFNC can increase hospital length of stay perhaps because there is a lack of evidence to guide weaning strategies.We aim to conduct a pilot study to identify the most effective weaning strategy for infants, up to 12 months, supported on HFNC for bronchiolitis. This may lead to reduced time on respiratory support and shorter length of stay. If this pilot study is deemed feasible, it will inform a larger multicentre trial.
This open label, non-blinded, randomised controlled trial will be conducted over 24 months at the Noah's Ark Children's Hospital for Wales, Cardiff, and will aim to recruit 20 patients. It will compare high-flow only weaning (high-flow discontinued at FiO of 21%) to HFNC and low-flow weaning (HFNC discontinued at 30% and replaced by low-flow up to 2 L/min). HFNC therapy will be delivered at 2 L/kg/min (maximum 20 L/min). The primary outcome is to examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC. Secondary outcomes include the time from decision to wean HFNC to the patient no longer requiring respiratory support and a safety assessment of the weaning strategies.
Health Research Authority and Health and Care Research Wales approval was granted on 8 September 2020 following review by the NHS research ethics committee.The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal, via websites and newsletters.
NCT04287959.
基于病房的高流量鼻导管（HFNC）是治疗标准氧疗失败的毛细支气管炎患儿的有效疗法。然而，HFNC 可能会增加住院时间，这可能是因为缺乏指导撤机策略的证据。我们旨在进行一项试点研究，以确定毛细支气管炎患儿使用 HFNC 支持时最有效的撤机策略。这可能会减少呼吸支持时间和缩短住院时间。如果这项试点研究被认为是可行的，它将为更大规模的多中心试验提供信息。
这项开放标签、非盲、随机对照试验将在加的夫的威尔士诺亚方舟儿童医院进行 24 个月，目标招募 20 名患者。它将比较高流量单独撤机（FiO 为 21%时停止高流量）与 HFNC 和低流量撤机（HFNC 在 FiO 为 30%时停止，并由低流量代替，最高可达 2 L/min）。HFNC 治疗将以 2 L/kg/min（最大 20 L/min）的流量输送。主要结局是检验毛细支气管炎需要 HFNC 的婴儿采用不同撤机策略的可行性。次要结局包括从决定撤机 HFNC 到患者不再需要呼吸支持的时间以及撤机策略的安全性评估。
2020 年 9 月 8 日，在 NHS 研究伦理委员会审查后，获得了英国健康研究管理局和威尔士健康与护理研究局的批准。赞助商是卡迪夫和 vale 大学健康委员会。我们将在同行评议的医学期刊、网站和时事通讯上发表研究结果。
NCT04287959。
