Introduction and background
Introduction
Study rationale
Background
There is a high burden of respiratory sequelae for children hospitalized with bronchiolitis
Bronchiolitis is a heterogeneous disease in both presentation and later childhood outcomes, but post-acute recurrent respiratory symptoms are a common element
Environmental exposures, including indoor air quality, influence respiratory health and are unstudied targets for prevention of recurrent respiratory symptoms after bronchiolitis
Summary
Methods/design
Risk/benefit assessment
Known potential risks
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• There is potential for false reassurance that the intervention prevents all adverse home environmental exposures.
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• Noise produced by the device may be considered by some to be a “white noise” but could be bothersome or harmful if the highest setting is used continuously in close proximity to the child.
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• The device may take up space, causing inconvenience.
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• Participating individuals could be injured or experience electrical shock during instrument installation or use in the home (childproofing required).
Known potential benefits
Assessment of potential risks and benefits
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• The study team will provide education that HEPA filtration will not prevent all adverse environmental exposures. Even though HEPA filtration can improve IAQ, it does not decrease all of the harmful contaminants that can be in the indoor environment. The study team will also emphasize that it is not known if the intervention provides any clinical benefit.
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• The HEPA unit chosen produces less noise and takes less space than some other available units. In the recommended “high” setting, the noise generated is below the American Academy of Pediatrics recommendation for sound level in a neonatal intensive care unit [82] and quieter than typical speech and rainfall [83]. We will instruct parent(s)/guardian(s) not to use the max setting and to set up the filtration unit at least 5 feet from where the child sleeps. In addition, these instructions will be placed on a label attached to the filtration unit.
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• The study team will guide equipment setup, maintenance, and safe use.
Objectives and endpoints
Primary objective
Secondary objective 1
Secondary objective 2
Secondary objective 3
Study design
Overall design
Scientific rationale for study design
Evaluation/procedures | Screen1 (hospital) | Enroll / randomize In hospital (+ 1 week) | Pre-intervention Weeks 1–2 after hospital discharge2 | Intervention2 Weeks 3–26 | Intervention Week 26 |
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Review inclusion/exclusion criteria | x | x | |||
Informed consent | x | ||||
Document participant characteristics and risk factors for recurrent wheeze | x | x | |||
Pre-intervention period (in all study participant homes—both intervention and control): up to 2 weeks continuous home PM2.5 monitoring via PurpleAir3 | x | ||||
Intervention period (in all study participant homes—both HEPA/control unit): Continuous home PM2.5 monitoring via PurpleAir3 | x | ||||
Continuous HEPA/control unit use4 | x | ||||
Continuous use of kilowatt meter to measure HEPA/control unit adherence4 | x | ||||
Weekly submission: Symptom survey, number of medical visits, number of nights away from home, HEPA/control unit adherence5 | x | x | |||
Check-in contact with study team6 | x | x | |||
QOL Survey5 | x |
End of study definition
Study population
Inclusion criteria
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Age < 12 months at hospital admission
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First-time hospitalization for bronchiolitis
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One primary residence (> 5 days per week)
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Parent, legal guardian or other legally authorized representative consents to allow their child to participate and agrees to participate in all study activities
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Electricity in the home (required to power the study equipment)
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Wireless internet access or cellular service access in the home
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English- or Spanish-speaking parent or guardian
Exclusion criteria
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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 guidelines) [88]
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Use of stand-alone home HEPA filtration other than study-related HEPA units in the home
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Household member who smokes (any type), vapes, or uses e-cigarettes
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Intention to move in the next 6 months
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Enrolled or plans to enroll in an interventional clinical trial for treatment of acute bronchiolitis or sequelae of bronchiolitis, unless permission is given by the PI
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Another child in the household is enrolled in this study (one child per household can enroll)
Screen failures
Strategies for recruitment and retention
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Screening. Local sites will obtain a daily list or receive notification of admissions to their pediatric units with a diagnosis of bronchiolitis (of the days where the research team is available). This information will be obtained in accordance with individual institutional policies and procedures as well as IRB approval from the IRB of record. For non-Native American populations, the UAMS IRB (as central IRB), will be the IRB of record.
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Recruitment. Each potential participant on the list should be approached for recruitment if the child meets eligibility criteria from prescreening their medical record. Recruitment can occur in person or remotely in accordance with institutional requirements, family preference, and healthcare team approval.
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Weekly and as needed check-in: (site to conduct a weekly check-in at a minimum)
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Assist or prompt EDC documentation as needed
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Assess equipment set-up, questions/concerns
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Safety assessments (AE, SAE, UPIRTSO)
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Monthly and as needed: (site and participant dependent)
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Assist or prompt EDC documentation as needed
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Assess equipment questions/concerns
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Safety assessments (AE, SAE, UPIRTSO)
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Weekly survey collection (26 submissions)—$20 per survey submitted (max $520 per participant)
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$10 for submitting QOL survey
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$5 each for baseline and 6-month (approx. week 26 of participation; week 24 of intervention) history question set (max $10)
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$40 for return of the PurpleAir monitors with internal SD cards, hotspot, and kW meter. This is for time spent returning equipment. Parent(s)/guardians of participant will receive pre-paid materials for returning equipment, i.e., at no expense to parent/guardian.
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$15 per family (The anticipated excess energy cost is approximately $5 per HEPA unit in higher energy cost areas. The $15 compensation will account for unanticipated energy costs.)
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Healthy Homes Kit: All participants will receive a Healthy Homes Kit (approximately $42.00 value) near the start of their child’s study intervention period. The kit contains a collection of items to improve non-IAQ home environmental health and safety. The Healthy Homes Kit is a response to community and stakeholder feedback requesting meaningful home environmental tools in all study arms to make the study more acceptable. We do not expect an impact on the measured outcomes. The rationale for using the Healthy Homes Kit is that the home environment is generally considered important for overall health. The Kit addresses the following concerns: (1) recruitment and retention may be affected with a “placebo only” arm, and (2) when introduced to the rationale that a healthy home environment helps improve health, some families may want to pursue home environment modifications, and the kit will provide standard tools. The kit will contain children’s books, outlet covers, doorknob covers, cabinet and drawer latches, bath thermometer, carbon monoxide detector, bedbug traps, and green cleaning supplies.
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Additional incentive at study completion and equipment retained by families: All families will retain the two HEPA units (value of $500) and receive a supply of two HEPA and carbon filters (value of $160). They also will keep the tape measure (value of $15), four surge protector power cords (value of $10 each) and one USB/AC power adapter (value of $4). They will keep their backpack (valued at approx. $22).
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Total possible compensation (reimbursement for time and equipment return) for study activities: $580
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Compensation for excess energy costs: $15.
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Value (approx.) of equipment and supplies that families keep: $806.
Study intervention
Study interventions administration
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Use of the HEPA units (experimental) or control units takes place from weeks 3–26 (approximately) after hospital discharge to home.
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A coordinator or other qualified research team member will contact the family via video or phone to prompt them to begin using the HEPA or control units. The research team member will confirm proper installation and that the two units are functioning and provide information on the lights (e.g., sensor light) on the units.
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Both the HEPA and carbon filters will be removed from the control units, and interior contents of the unit will be masked with black cardstock or similar. The door on the unit will be taped closed to make it difficult to open the units.
Preparation/handling/storage/accountability
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2 HEPA or control units (unless home is small enough that only one HEPA unit is needed),
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2 kW meters (0 kW meters if home has only two-prong outlets),
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2 PurpleAir monitors (1 if home using only one HEPA unit) and mobile hotspot with power adapter,
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4 power strips or similar,
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1 tape measure,
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Basic education on strategies to improve indoor air quality, and
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1 Healthy Homes Kit.
Study intervention discontinuation and participant discontinuation/withdrawal
Discontinuation of study intervention
Participant discontinuation/withdrawal from the study
Lost to follow-up
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Study staff will attempt to contact the parent/guardian of the participant and obtain the study survey data within 2 business days for weekly surveys and within 7 business days for quality of life surveys. They will also counsel the parent/guardian of the participant on the importance of maintaining the assigned study activity schedule on behalf of their enrolled child and ascertain if the parent/guardian of the participant wishes to have their child continue in the study.
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Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to regain contact with the parent/guardian of the participant (at least three telephone calls, and, if necessary, a certified letter to the last known mailing address of the parent/guardian of the participant). These contact attempts will be documented in the participant’s study file.
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Should the participant’s parent/guardian continue to be unreachable, he or she will be considered to have withdrawn from the study with a primary reason of lost to follow-up.
Study assessments and procedures
Efficacy assessments
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Age (in months) at initial hospitalization for bronchiolitis (medical record review)
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Gestational age at birth (parental report or medical record review)
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Sex/gender (parental report or medical record review)
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Race/ethnicity (parental report or medical record review)
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Parental education
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U.S. Census Tract Rural/Urban (RUCA code) based on residential address
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Viral test results (first hospital admission for bronchiolitis) if available per standard of care testing (medical record review)
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Season of hospitalization for bronchiolitis (medical record review)
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Highest level of respiratory support during bronchiolitis admission (medical record review)
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History of previous wheezing with illness
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Family history of asthma
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Wood stove use in the home (and whether this is the primary heat source)
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Central air conditioning in the home
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Type of cooking stove in the home
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Presence of hood above cooking stove in home
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Use of hood while cooking
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Risk of higher frequency of viral exposures
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◦ Daycare attendance
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◦ Number of children in home
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◦ Number of children in home in daycare or school
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◦ Household crowding
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Presence of plumbed (running) water
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Furry pets in the home
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Baseline weekly average PM2.5 home measurements (Purple Air Monitor data report)
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Atopic dermatitis
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Chronic use of asthma medications preceding bronchiolitis hospitalization
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Use of asthma medications with illness preceding bronchiolitis hospitalization
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Received systemic steroid during hospitalization for bronchiolitis (medical record review)
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Square footage of rooms containing HEPA units (during intervention set-up)
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Smokers who live in the home
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Chronic use of asthma medications
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New prescriptions for asthma medications or antibiotics with healthcare visits for respiratory symptoms (determined from weekly survey entries)
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Atopic dermatitis
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Immunization status
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Average number of nights per week away from home (calculated from study data)
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Average number of days per week where the child was away from home more than 6 h (calculated from study data)
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Weekly outdoor PM2.5 concentration (These data may be obtained after the 26-week study period)
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Continuous PM Assessment: Families will install PurpleAir PA-II-SD continuous sensors in the common room and child’s sleep space. The sensor measures numerous environmental factors, but PM2.5 is of primary interest. The PurpleAir is 3.5 × 3.5 × 5 inches and weighs 25 oz with the power supply. The distance from the filtration unit to the PurpleAir will be measured by the family with a tape measure and reported to the study team. Study team personnel will schedule a phone call or video meeting for each family with technical support personnel to assist with equipment setup.
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Each PurpleAir is WiFi-enabled. So that the monitor use does not interfere with a family’s WiFi usage, each participating home will be provided with one mobile password-protected hot spot and necessary data. One hot spot is sufficient to serve both PurpleAirs. The PurpleAir monitors will be connected to the hot spot prior to mailing (done centrally prior to receipt of the monitors by individual study sites) to simplify set up of monitors by participating families.
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PurpleAir sensor data can be retrieved from a public website. However, all sensors used in this study will be kept private to protect participant privacy. Data will be retrieved by University of Montana central site personnel from private sensors using a PurpleAir application programming interface (API) key using automated methods. Data retrieval will occur at frequent intervals to ensure the sensor is operating properly. University of Montana central site staff will perform quality checks on the data, and, if issues arise, they will communicate with coordinators and/or families to troubleshoot the problem or opt to rely on data from the security digital card (see below). If needed, staff will provide additional training or a new instrument. Details of data retrieval, quality assurance, adherence, and data analysis are described in coordinator instructions and checklists and the Data Safety and Monitoring Plan.
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Each PurpleAir is equipped with a security digital (SD) card that logs PM2.5 data in the event of WiFi interruptions. The SD card has sufficient storage to hold at least 6 months of PM2.5 data so that it does not need to be changed during follow-up. The family will mail the PurpleAirs back to the ISPCTN site (or designated central site, i.e., the University of Montana) at the end of follow-up. Research staff will then remove the SD card and download the data. Data obtained through WiFi are considered primary; however, data from the SD card will be used to infill any missing observations. The University of Montana central site team will provide final summary PM2.5 metrics to the DCOC.
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Symptom survey: The survey captures three daytime symptoms (cough, wheeze, trouble breathing) and nighttime awakenings due to cough. The responses to the symptom survey in the EDC will be used to determine SFDs. The questions have been used previously to measure SFDs after bronchiolitis over a similar time frame of approximately 6 months in a study testing whether an intervention reduces post-bronchiolitis symptomatic days [5]. The questions are based on the Bronchiolitis Caregiver Diary, a validated measurement tool for respiratory symptoms after acute bronchiolitis [37]. These questions have been used to follow post-bronchiolitis symptoms over a 20-week period, similar to this study [5]. The survey will ask whether the child had any cough, wheeze, or trouble breathing this week (Y/N).
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If No, they will move on to the next section for healthcare visits.
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If Yes, they will receive a prompt for each day to respond Y/N for the presence of the symptom and if there are symptoms present, the survey will ask if any medications were used for respiratory symptoms (family to list names of medications).
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Healthcare visits: The parent/guardian will record the number of hospitalizations, ED/UC visits, and other medical visits for respiratory symptoms. This will be a (Y/N) for whether they participant (child) had a healthcare visit in the past week. If Y, there will be a prompt to enter the number of visits for each visit type. If N, they will move on to the next section, “Time away from home.”
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Time away from home:
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◦ Days away from home: The parent/guardian will be prompted to enter how many days that week the child spent more than 6 h outside the home (0–7 days).
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◦ Nights away from home: The parent/guardian will be prompted to enter how many nights that week the child spent away from their primary residence (away for vacation, staying with someone else, etc.) (0–7 days).
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Equipment use:
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◦ HEPA/control unit use: For each room with a HEPA/control unit, the parent/guardian will be asked to respond Yes/No to whether they used unit and asked to report the usual setting used (1, 2, 3, or 4). If applicable, the parent(s)/guardian(s) will also record the numerical reading visible on the kW meter attached to each HEPA/control unit. This will be a simple entry of two numbers to respond to the survey prompt.
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◦ PurpleAir monitor: The parent/guardian will be asked whether the monitor is plugged in with the light on (Yes or No). They will also be asked whether the hot spot is on with bar light and 3 lighted dots on (Yes or No).
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The PedsQLTM Pediatric Quality of Life Inventory Infant Scales [99] questionnaire will be administered to a parent/guardian at the end of the intervention period. This is a validated outcome measure of QOL for infants 1–12 months (36 items) and 13–24 months (45 items). The constructs include 5 subdomains: physical functioning, physical symptoms, emotional functioning, and cognitive functioning. The questionnaire will be administered online. The alternative will be for the research coordinator to obtain responses verbally.
Safety and other assessments
Adverse events and serious adverse events
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Death
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A life-threatening adverse event
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Inpatient hospitalization or prolongation of existing hospitalization
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Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
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Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition
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Mild—Events require minimal or no treatment and do not interfere with the participant’s daily activities.
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Moderate—Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning.
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Severe—Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating. Of note, the term “severe” does not necessarily equate to “serious.”
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Definitely related—There is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled out. The clinical event, including an abnormal laboratory test result, occurs in a plausible time relationship to study intervention administration and cannot be explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the study intervention (dechallenge) should be clinically plausible. The event must be pharmacologically or phenomenologically definitive, with use of a satisfactory rechallenge procedure if necessary.
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Probably related—There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within a reasonable time after administration of the study intervention, is unlikely to be attributed to concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition.
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Potentially related—There is some evidence to suggest a causal relationship (e.g., the event occurred within a reasonable time after administration of the intervention). However, other factors may have contributed to the event (e.g., the participant’s clinical condition, other concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it can be flagged as requiring more information and later be upgraded to “probably related” or “definitely related”, as appropriate.
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Unlikely to be related—A clinical event, including an abnormal laboratory test result, whose temporal relationship to study intervention administration makes a causal relationship improbable (e.g., the event did not occur within a reasonable time after administration of the study intervention) and in which other drugs or chemicals or underlying disease provides plausible explanations (e.g., the participant’s clinical condition, other concomitant treatments).
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Not related—The AE is completely independent of study intervention administration, and/or evidence exists that the event is definitely related to another etiology. There must be an alternative, definitive etiology documented by the clinician.
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Cough
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Wheeze
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Trouble breathing
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Medical or emergency department/urgent care visit for respiratory complaint
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Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are described in the protocol-related documents, such as the Institutional Review Board (IRB)-approved research protocol and informed consent document and (b) the characteristics of the participant population being studied;
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Related or possibly related to participation in the research (“possibly related” means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
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Suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Unanticipated problem reporting
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Protocol identifying information: protocol title and number, PI’s name, and the IRB project number
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Event date
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Event location
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Nature of the risk
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How the risk relates to research
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A detailed description of the event, incident, experience, or outcome
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A description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the UP
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Breach of confidentiality
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Manufacturer recall of equipment used in the protocol
Statistical considerations
Statistical hypotheses
Sample size determination
Populations for analyses
Statistical analyses
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Descriptive statistics: All numerical variables will be summarized using mean ± standard deviation and median (minimum, maximum). All categorical variables will be summarized using frequency (in %).
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Inference tests: All proposed statistical tests are two-sided. A p-value < 0.05 is considered statistically significant.
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Covariates: Covariates will be compared between groups (intervention vs. control) using two sample t-tests, or Wilcoxon rank sum tests if they are continuous variables, and chi-square tests or Fisher’s exact tests if they are categorical variables. Each of the continuous covariate variables will be assessed of its correlation to the primary endpoint, or each of the secondary endpoints using Pearson’s correlation coefficient or Spearman’s correlation coefficient. Similarly, each of the categorical covariate variables will be assessed of its association to the primary endpoint, or each of the secondary endpoints using an ANOVA model, or a Kruskal–Wallis test. A covariate showing a significant association to intervention, a significant correlation or association to the primary (or secondary) endpoint will be considered as the adjusting (controlling) covariate and will be added as adjusting independent variable in the statistical models proposed for primary and secondary analyses.
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Model assumptions: Primary and secondary endpoints will be inspected of normal distribution assumptions using the histogram plots. If the variable is noticeably right (or seldomly left) skewed, then a transformation variable will be used in the parametric models to ensure the assumption of normality is met. As an alternative approach, a generalized linear model will be proposed to the variable using a distribution assumption fitting the data properly.
Analysis of the primary efficacy endpoint
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Primary objective: To test the efficacy of a HEPA filtration unit home intervention, relative to the control arm, with respect to respiratory symptom burden (as measured by symptom-free days; SFD) over 24 weeks following activation of filtration.
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Primary endpoint: Number of caregiver-reported SFDs over 24 weeks following activation of filtration (SFD defined as a 24-h period without coughing, wheezing, or trouble breathing).
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Statistical hypothesis: Mean of SFDs in the HEPA filtration home intervention group is larger than mean of SFDs in the control group. The hypothesis testing is the comparison of superiority.
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Statistical procedures: The hypothesis will be tested using a mixed effect model after accounting for within cluster correlation. The model uses the primary endpoint as the dependent variable, and the intervention effect (intervention vs. control) as the independent variable or the fixed effect with site as a random effect.
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Missing data: The primary endpoint will be imputed if there is any missing observation in the ITT. The statistician will assess the missing patterns to determine if the cause of missing is missing at random (MAR), missing completely at random (MCAR), or missing not at random (MNAR). Imputation methods such as multiple imputation (MI) methods and pattern-mixture methods will be used in imputation and analyses.
Analysis of the secondary endpoints
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Secondary endpoint 1: Caregiver-reported unscheduled healthcare visits. The proposed statistical method will be a generalized mixed effect model. The dependent variable will be counts of unscheduled health care visits from each of the metrics or the sum of all metrics. Each variable of counts is considered to follow a negative binomial distribution and its log link will be used to connect the independent variable, or the fixed effect of intervention effect with site as a random effect.
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Secondary endpoint 2: Total PedsQLTM Infant Scales score. The proposed statistical model will be a mixed effect model using Total PedsQL score as the dependent variable, the intervention effect as the fixed effect, with site as a random effect. Means (and SEs) of Total PedsQL score estimated from the mixed effect model will be presented in the final result and compared between groups through a p-value to reach a statistical conclusion of significance and superiority.
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Secondary endpoint 3: PM2.5 levels. The proposed statistical model will be a mixed effect model using PM2.5 level as the dependent variable, and the intervention effect as the fixed effect, and site as a random effect. Means and SEs of PM2.5 level from the mixed effect model will be presented in the final result. A p-value of the difference of means between groups will be used to reach a statistical conclusion of significance and superiority.
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Missing data: Missing data of secondary endpoint will be assessed of causes of missing and imputed in analyses, following the same methods proposed for the primary endpoint.
Safety analyses
Planned interim analyses
Analysis | Information fraction | Reject H0 (efficacy) | Overall α spent | Reject H1 (futility) | Overall β spent |
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Interim | 0.50 | |zz|> 2.963 | 0.0003 | |zz|< 0.200 | 0.012 |
Final | 1.00 | |zz|> 1.969 | 0.05 | |zz|< 1.969 | 0.102 |
Sub-group analyses Page 55 line 1264–1267
Supporting documentation and operational considerations
Regulatory, ethical, and study oversight considerations
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Determination of unexpected, significant, or unacceptable risk to participants
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Insufficient compliance to protocol requirements
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Data that are not sufficiently complete and/or evaluable
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Evidence of study futility of the primary endpoint
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NIH Public Access Policy, which ensures that the public has access to the published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.
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ECHO ISPCTN Publications and Presentations Policy, which ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials. The ECHO ISPCTN Steering Committee has approved and ratified the ECHO ISPCTN Publications and Presentations Policy, which includes representatives from all site awardees, as well as representatives from the NIH and the DCOC.
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NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission Rule. We will register this trial at ClinicalTrials.gov, and we will submit trial results to ClinicalTrials.gov. In addition, we will make every attempt to publish results in peer-reviewed journals. Other researchers may request data from this trial by contacting Jeannette Lee, PhD, at the DCOC.
Trial status
Trial registration—data set
Data category | Information |
Primary registry and trial identifying number | ClinicalTrials.gov NCT05615870 |
Date of registration in primary registry | 14 November, 2022 |
Secondary identifying numbers | n/a |
Source(s) of monetary or material support | National Institutes of Health |
Primary sponsor | NIH, Environmental Influences on Child Health Outcomes (ECHO) Program Institutional Development Award (IDeA) States Pediatric Clinical Trials Network |
Secondary sponsor(s) | n/a |
Contact for public queries | Lora A Lawrence, RN lawrenceloraa@uams.edu |
Contact for scientific queries | Jessica Snowden, MD,MS,MHPTT JSnowden@uams.edu |
Public title | Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (BREATHE) |
Scientific title | Bronchiolitis Recovery and the Use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study) |
Countries of recruitment | United States |
Health condition(s) or problem(s) studied | Bronchiolitis (post-acute bronchiolitis respiratory symptoms) |
Intervention(s) | Active comparator: HEPA filtration (Winix 5500–2 HEPA filtration units) |
Placebo comparator: Identical appearing placebo Winix unit without HEPA or carbon filters | |
Key inclusion and exclusion criteria | Ages eligible for study: < 12 months Sexes eligible for study: both Accepts healthy volunteers: yes |
Inclusion criteria: • 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 | |
Exclusion criteria: • 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) | |
Study type | Interventional |
Allocation: Randomized Intervention model: Parallel assignment Multi-center, parallel, double-blind, randomized controlled clinical trial; triple masking (Participant, Care Provider, Investigator) Framework: Superiority | |
Primary purpose: prevention | |
Phase: n/a | |
Date of first enrolment | November 7, 2022 |
Target sample size | 228 |
Recruitment status | Recruiting |
Primary outcome(s) | Determine if use of HEPA filtration units reduces respiratory symptom burden for 24 weeks compared to use of control units |
Key secondary outcomes | 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 PM2.5 levels in the home |
Acknowledgements
Sponsor
U24 OD024957 | Data Coordinating and Operations Center for the ECHO IDeA States Pediatric Clinical Trials Network |
UG1 OD024942 | University of Mississippi Medical Center |
UG1 OD024943 | University of Kansas Medical Center |
UG1 OD024944 | Alaska Native Tribal Health Consortium |
UG1 OD024945 | Arkansas Children's Research Institute |
UG1 OD024946 | Dartmouth College (New Hampshire) |
UG1 OD024947 | University of New Mexico Health Sciences Center |
UG1 OD024948 | University of Hawaii at Manoa |
UG1 OD030016 | West Virginia University |
UG1 OD024950 | University of Oklahoma Health Sciences Center |
UG1 OD024951 | Rhode Island Hospital |
UG1 OD024952 | University of Montana |
UG1 OD024953 | University of Nebraska Medical Center |
UG1 OD024954 | University of Louisville |
UG1 OD024955 | University of Vermont and State Agricultural College |
UG1 OD024956 | University of South Carolina at Columbia |
UG1 OD024959 | Louisiana State University Pennington Biomedical Research Center |
UG1 OD030019 | Avera Research Institute Center for Pediatric and Community Research |