Bronchiolitis
Conditions
Keywords
Children<12 months of age hospitalized with bronchiolitis
Brief summary
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.
Detailed description
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.
Interventions
OTHERWinix 5500-2 HEPA filtration units
To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit.
Sponsors
University of Vermont Medical Center
University of Montana
National Institutes of Health (NIH)
IDeA States Pediatric Clinical Trials Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
This is a multi-center, parallel, double-blind, randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 12 Months
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Caregiver-reported Symptom-free Days (SFDs) | 24 Weeks | An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | 24 weeks | Caregiver reported number of hospitalizations, emergency department or urgent care visits, other unscheduled medical visits, and the sum of total counts of all metrics for respiratory complaints |
| Total Quality of Life (QOL) Score | 24 weeks | QOL score is measured by the Pediatric Quality of Life Inventory TM (PedsQLTM) Infants Scales questionnaire. The scores are reverse-scored and linearly transformed to a 0-100 scale. Higher scores mean a better outcome. |
| Average Particulate Matter (PM2.5) Levels | 24 weeks | PM2.5 levels (Particulate Matter ≤ 2.5 micrometers in diameter) are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week. Higher levels mean a worse outcome. |
Countries
United States
Participant flow
Pre-assignment details
Two enrolled participants terminated the study prior to randomization due to withdrawal of consent and ineligibility.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (Active Filter) The intervention group will use two Winix 5500-2 HEPA filtration units (Appendix A) (https://winixamerica.com/product/5500-2/). One will be placed in the child's sleep space and one will be placed in another common room with both units running continuously on the high (i.e., level 3 / second from highest) setting. Each unit is 8.2 x 15.0 x 23.6 inches, and verified for a 360 sq. foot room. If a home is too small to accommodate 2 Winix units (for example, a single room residence'), one Winix unit may be used for the study. Additional features beyond HEPA and carbon filter, include plasmawave technology to reduce volatile organic compounds and odors. The plasmawave feature will be turned off to avoid ozone production.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit. | 113 |
| Control Group (No Filter) The control group will use identical-appearing Winix 5500-2 units and identical setup procedures as described above, but with no HEPA or carbon filters.
Winix 5500-2 HEPA filtration units: To determine if use of a HEPA filtration unit home intervention reduces the respiratory symptom burden (symptom-free days; SFD) for 24 weeks compared to a use of a control unit. | 115 |
| Total | 228 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 13 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Terminated from the experimental or control intervention only and continued with the study | 1 | 0 |
| Overall Study | The participant thought the study was done and shipped the devices back. | 0 | 1 |
| Overall Study | Unable to complete study activities after moving residences | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Intervention Group (Active Filter) | Control Group (No Filter) | Total |
|---|---|---|---|
| Age, Continuous | 4.0 Months STANDARD_DEVIATION 2.9 | 4.3 Months STANDARD_DEVIATION 2.9 | 4.1 Months STANDARD_DEVIATION 2.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 12 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 102 Participants | 196 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 16 Participants | 29 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 14 Participants | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 70 Participants | 74 Participants | 144 Participants |
| Rurality (RUCA code) Metropolitan | 79 Participants | 78 Participants | 157 Participants |
| Rurality (RUCA code) Micropolitan | 9 Participants | 14 Participants | 23 Participants |
| Rurality (RUCA code) Rural | 19 Participants | 9 Participants | 28 Participants |
| Rurality (RUCA code) Small town | 5 Participants | 12 Participants | 17 Participants |
| Rurality (RUCA code) Unknown | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 41 Participants | 49 Participants | 90 Participants |
| Sex: Female, Male Male | 72 Participants | 66 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 115 |
| other Total, other adverse events | 7 / 113 | 11 / 115 |
| serious Total, serious adverse events | 17 / 113 | 12 / 115 |
Outcome results
Primary
Number of Caregiver-reported Symptom-free Days (SFDs)
An SFD is defined as a 24-hour period without coughing, wheezing, or trouble breathing
Time frame: 24 Weeks
Population: The analysis population included all participants who were randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) with available outcome data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Active Filter) | Number of Caregiver-reported Symptom-free Days (SFDs) | 118.01 Days | Standard Deviation 42.66 |
| Control Group (No Filter) | Number of Caregiver-reported Symptom-free Days (SFDs) | 112.60 Days | Standard Deviation 46.33 |
Comparison: Null hypothesis: mean of SFDs in the HEPA filtration home intervention group will not differ from the mean of SFDs in the control groupp-value: 0.53795% CI: [-11.77, 22.6]Mixed Models Analysis
Secondary
Average Particulate Matter (PM2.5) Levels
PM2.5 levels (Particulate Matter ≤ 2.5 micrometers in diameter) are measured by in-home monitors and scaled to unit of micrograms per cubic meter per week. Higher levels mean a worse outcome.
Time frame: 24 weeks
Population: Participants who were randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) with available PM2.5 data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group (Active Filter) | Average Particulate Matter (PM2.5) Levels | Common room | 10.70 µg/m³/week | Standard Deviation 15.91 |
| Intervention Group (Active Filter) | Average Particulate Matter (PM2.5) Levels | Sleep space | 11.08 µg/m³/week | Standard Deviation 18.77 |
| Intervention Group (Active Filter) | Average Particulate Matter (PM2.5) Levels | Average of common room and sleep space | 10.66 µg/m³/week | Standard Deviation 15.53 |
| Control Group (No Filter) | Average Particulate Matter (PM2.5) Levels | Common room | 15.27 µg/m³/week | Standard Deviation 16.86 |
| Control Group (No Filter) | Average Particulate Matter (PM2.5) Levels | Sleep space | 21.45 µg/m³/week | Standard Deviation 33.14 |
| Control Group (No Filter) | Average Particulate Matter (PM2.5) Levels | Average of common room and sleep space | 17.96 µg/m³/week | Standard Deviation 21.35 |
Comparison: Null hypothesis: the mean of the PM2.5 level of the common room and sleep space in the intervention group will not differ from the mean of the PM2.5 level in the control groupp-value: <0.00195% CI: [-10.98, -3.42]Mixed Models Analysis
Secondary
Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints
Caregiver reported number of hospitalizations, emergency department or urgent care visits, other unscheduled medical visits, and the sum of total counts of all metrics for respiratory complaints
Time frame: 24 weeks
Population: The analysis population included all participants who are randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) with available data of Unscheduled Healthcare Visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group (Active Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | Hospitalizations | 0.28 Visits | Standard Deviation 0.91 |
| Intervention Group (Active Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | Emergency Department (ED) or Urgent Care (UC) visits | 0.68 Visits | Standard Deviation 1.25 |
| Intervention Group (Active Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | Other unscheduled healthcare visits (UHVs) for respiratory complaints | 1.11 Visits | Standard Deviation 1.65 |
| Intervention Group (Active Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | A sum of counts (or total counts) of all metrics | 2.06 Visits | Standard Deviation 2.83 |
| Control Group (No Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | A sum of counts (or total counts) of all metrics | 2.31 Visits | Standard Deviation 2.84 |
| Control Group (No Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | Hospitalizations | 0.16 Visits | Standard Deviation 0.6 |
| Control Group (No Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | Other unscheduled healthcare visits (UHVs) for respiratory complaints | 1.48 Visits | Standard Deviation 1.99 |
| Control Group (No Filter) | Number of Hospitalizations, Emergency Department or Urgent Care Visits or Other Unscheduled Medical Visits for Respiratory Complaints | Emergency Department (ED) or Urgent Care (UC) visits | 0.68 Visits | Standard Deviation 1.32 |
Comparison: Null hypothesis: mean of counts of hospitalizations for respiratory symptoms in the intervention group will not differ from the mean of counts of hospitalizations for respiratory symptoms in the control groupp-value: 0.20595% CI: [-0.07, 0.3]Mixed Models Analysis
Comparison: Null hypothesis: mean of counts of emergency department or urgent care visits for respiratory symptoms in the intervention group will not differ from the mean of counts of emergency department or urgent care visits for respiratory symptoms in the control groupp-value: 0.99295% CI: [-0.35, 0.35]Mixed Models Analysis
Comparison: Null hypothesis: mean of counts of other unscheduled healthcare visits for respiratory symptoms in the intervention group will not differ from the mean of counts of other unscheduled healthcare visits for respiratory symptoms in the control groupp-value: 0.17295% CI: [-0.9, 0.16]Mixed Models Analysis
Comparison: Null hypothesis: mean of counts (or total counts) of visits of all metrics for respiratory symptoms in the intervention group will not differ from the mean of counts of visits of all metrics for respiratory symptoms in the control groupp-value: 0.5395% CI: [-1.02, 0.52]Mixed Models Analysis
Secondary
Total Quality of Life (QOL) Score
QOL score is measured by the Pediatric Quality of Life Inventory TM (PedsQLTM) Infants Scales questionnaire. The scores are reverse-scored and linearly transformed to a 0-100 scale. Higher scores mean a better outcome.
Time frame: 24 weeks
Population: Participants who were randomized to either HEPA filtration (intervention group) or inactive filter unit (control group) and answered the quality of life (QOL) survey.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group (Active Filter) | Total Quality of Life (QOL) Score | 81.34 Scores on a scale | Standard Deviation 9.99 |
| Control Group (No Filter) | Total Quality of Life (QOL) Score | 82.13 Scores on a scale | Standard Deviation 10.68 |
Comparison: Null hypothesis: mean of the Child QOL score in the HEPA intervention group will not differ from the mean of Child QOL score in the control groupp-value: 0.59895% CI: [-3.75, 2.16]Mixed Models Analysis