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临床试验/NCT05615870
NCT05615870已完成不适用

Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters

IDeA States Pediatric Clinical Trials Network34 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2022年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
34
主要终点
Number of Caregiver-reported Symptom-free Days (SFDs)

研究概览

简要总结

This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Children <12 months of age hospitalized with bronchiolitis are 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) to improve indoor air quality (IAQ) or to a control group with filtration units without HEPA and carbon filters. The HEPA intervention units and control units will be used for 24 weeks after pre-intervention IAQ measurements. Children are followed for respiratory outcomes over the pre-intervention and intervention periods.

详细描述

This is a multi-center, parallel, double-blind, randomized controlled clinical trial. Two hundred twenty-eight children <12 months old with their first hospitalization for bronchiolitis will be randomized 1:1 (stratified by site) to receive 24 weeks of home intervention with active HEPA filtration units to improve IAQ or to a control group without a HEPA or carbon filter inside identical-appearing units. Children will be followed for respiratory symptoms during a pre-intervention period of up to two weeks following randomization and during an intervention period of 24 weeks.

This study is designed to reduce barriers to participation for rural participants in that there will be no required study visits to a distant study site, and all study activities and data collection will be conducted remotely. Participants will be identified in hospitals in ISPCTN states, maximizing the chances that rural and medically underserved populations are represented. It is common for rural children with bronchiolitis to be transferred to tertiary care centers in urban/suburban locales, so inclusion of urban hospitals will allow for recruitment of this population.1 It is important for rural children to be represented in a bronchiolitis study in order to increase generalizability. Rural and underserved children have a higher risk of decreased access to medical care for symptoms and illness episodes, and a higher burden of asthma.83,84 These families may have air pollutant exposure profiles distinct from those residing in urban areas. For example, they might experience less exposure to traffic-related pollutants but may have more wood stove use or exposure to agricultural pollutants or wildfires. With its diversity of sites, the ECHO ISPCTN is well-positioned to enroll rural children that might otherwise be excluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Families will be masked as to whether their Winix units are equipped with or without HEPA/carbon filters.

Study coordinators, investigators, and other team members who interact with participants' parent(s)/guardian(s) to obtain surveys, troubleshoot equipment setup and operation, or have other interactions will remain masked through the duration of the study for individual participants. This includes masking as to which intervention the participants receive and household air quality measurements, including the baseline measurements (separate personnel will need to be on the receiving end for air quality measurement data). This will require more than one study coordinator or additional staff/technician on the study team.

入排标准

年龄范围
1 Week 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age <12 months at hospital admission
  • First-time hospitalization for bronchiolitis
  • One primary residence (>5 days per week)
  • Parent, legal guardian or other legally authorized representative consents to allow their child to participate and agrees to participate in all study activities
  • Electricity in the home (required to power the study equipment)
  • Wireless internet access or cellular service access in the home*
  • English or Spanish-speaking parent or guardian

排除标准

  • Chronic airway or respiratory conditions requiring home oxygen, mechanical ventilation, or tracheostomy dependence; known immunodeficiency, hemodynamically significant cardiac conditions including those requiring medication or oxygen; cystic fibrosis; neuromuscular disease; eligible for palivizumab (per AAP guidelines87)
  • Use of stand-alone home HEPA filtration other than study-related HEPA units in the home
  • Household member who smokes (any type), vapes, or uses e-cigarettes
  • Intention to move in the next 6 months
  • Enrolled or plans to enroll in an interventional clinical trial for treatment of acute bronchiolitis or sequelae of bronchiolitis, unless permission given by the PI
  • Another child in the household is enrolled in this study (one child per household can enroll)

结局指标

主要结局

Number of Caregiver-reported Symptom-free Days (SFDs)

时间窗: 24 Weeks

An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing

次要结局

  • Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints(24 weeks)
  • Total Quality of Life (QOL) Score(24 weeks)
  • Average Particulate Matter (PM2.5) Levels(24 weeks)

研究者

发起方
IDeA States Pediatric Clinical Trials Network
申办方类型
Network
责任方
Sponsor

研究点 (34)

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