毛细支气管炎康复和高效空气过滤器（HEPA）的使用（BREATHE 研究）：一项多中心、平行、双盲、随机对照临床试验的研究方案。

Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial.

机构信息

Department of Pediatrics, Larner College of Medicine at the University of Vermont, 111 Colchester Ave, Smith 5, Burlington, VT, 05403, USA.

School of Public and Community Health Sciences, University of Montana, 177 Skaggs, Missoula, MT, 59812-2016, USA.

出版信息

Trials. 2024 Mar 20;25(1):197. doi: 10.1186/s13063-024-08012-0.

DOI:10.1186/s13063-024-08012-0

PMID:38504367

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10953277/

Abstract

BACKGROUND

Acute viral bronchiolitis is the most common reason for hospitalization of infants in the USA. Infants hospitalized for bronchiolitis are at high risk for recurrent respiratory symptoms and wheeze in the subsequent year, and longer-term adverse respiratory outcomes such as persistent childhood asthma. There are no effective secondary prevention strategies. Multiple factors, including air pollutant exposure, contribute to risk of adverse respiratory outcomes in these infants. Improvement in indoor air quality following hospitalization for bronchiolitis may be a prevention opportunity to reduce symptom burden. Use of stand-alone high efficiency particulate air (HEPA) filtration units is a simple method to reduce particulate matter ≤ 2.5 µm in diameter (PM), a common component of household air pollution that is strongly linked to health effects.

METHODS

BREATHE is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children < 12 months of age hospitalized for the first time with bronchiolitis will participate. Children will be randomized 1:1 to receive a 24-week home intervention with filtration units containing HEPA and carbon filters (in the child's sleep space and a common room) or to a control group with units that do not contain HEPA and carbon filters. The primary objective is to determine if use of HEPA filtration units reduces respiratory symptom burden for 24 weeks compared to use of control units. Secondary objectives are to assess the efficacy of the HEPA intervention relative to control on (1) number of unscheduled healthcare visits for respiratory complaints, (2) child quality of life, and (3) average PM levels in the home.

DISCUSSION

We propose to test the use of HEPA filtration to improve indoor air quality as a strategy to reduce post-bronchiolitis respiratory symptom burden in at-risk infants with severe bronchiolitis. If the intervention proves successful, this trial will support use of HEPA filtration for children with bronchiolitis to reduce respiratory symptom burden following hospitalization.

TRIAL REGISTRATION

NCT05615870. Registered on November 14, 2022.

摘要

背景

急性病毒性细支气管炎是美国婴儿住院的最常见原因。因细支气管炎住院的婴儿在随后的一年中患反复呼吸道症状和喘息的风险较高，并且存在长期不良呼吸后果，如持续性儿童哮喘。目前尚无有效的二级预防策略。多种因素，包括空气污染物暴露，都会增加这些婴儿发生不良呼吸后果的风险。改善细支气管炎住院后的室内空气质量可能是减少症状负担的预防机会。使用独立的高效微粒空气（HEPA）过滤装置是一种简单的方法，可以减少直径≤2.5μm 的颗粒物（PM），PM 是家庭空气污染的常见成分，与健康影响密切相关。

方法

BREATHE 是一项多中心、平行、双盲、随机对照临床试验。228 名<12 个月龄、首次因细支气管炎住院的儿童将参与研究。将儿童随机分为 1:1 组，分别接受为期 24 周的家庭干预，使用含有 HEPA 和碳过滤器的过滤装置（在儿童的睡眠空间和一个公共房间）或对照组使用不含 HEPA 和碳过滤器的装置。主要目标是确定与对照组相比，使用 HEPA 过滤装置是否能在 24 周内减轻呼吸道症状负担。次要目标是评估 HEPA 干预相对于对照组在以下方面的疗效：（1）因呼吸道投诉而未预约的医疗就诊次数，（2）儿童生活质量，和（3）家庭中的平均 PM 水平。