Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change in particulate matter concentrations (PM₁, PM₂.₅, PM₄, PM₁₀, TSP)
Study Overview
Brief Summary
Participant's baby was born prematurely and had underdeveloped lungs at birth. Most premature infants require mechanical ventilation after birth, which increases the risk of lung injury and may lead to varying degrees of bronchopulmonary dysplasia (BPD). Investigators believe that introducing an air purifier into your home environment after Participant's baby is discharged could help improve their lung development.
This study aims to non-invasively measure baby's transcutaneous carbon dioxide (PtcCO₂) levels and blood oxygen saturation (SpO₂) at home, both with and without the use of an air purifier. In addition, investigators will collect data from Kaohsiung Medical University Hospital medical records regarding the number of visits, respiratory status, height, weight, head circumference, and developmental progress. Health questionnaires will also be administered to assess changes in health outcomes and provide recommendations on improving indoor air quality in Participant's home.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 0 to 6 years who were born at less than 37 weeks of gestation.
Exclusion Criteria
- •Children born at more than 37 weeks of gestation.
Arms & Interventions
Comparison of Air Purifier Intervention and Frequency of Medical Visits
Study Arm: Experimental (Air Purifier On) vs. No Intervention (Air Purifier Off）
Intervention: air purifier (Device)
Outcomes
Primary Outcomes
Change in particulate matter concentrations (PM₁, PM₂.₅, PM₄, PM₁₀, TSP)
Time Frame: Baseline and up to 3 weeks after intervention
Indoor concentrations of PM₁, PM₂.₅, PM₄, PM₁₀, and total suspended particles (TSP) will be measured before and after the use of an air purifier. Unit of Measure:µg/m³
Change in gaseous pollutant concentrations (CH₂O, NO₂, CO, SO₂, VOC, CO₂)
Time Frame: Baseline and up to 3 weeks after intervention
Indoor gaseous pollutants, including formaldehyde (CH₂O), nitrogen dioxide (NO₂), carbon monoxide (CO), sulfur dioxide (SO₂), volatile organic compounds (VOC), and carbon dioxide (CO₂), will be measured before and after the intervention. Unit of Measure: ppm
Change in microbial concentrations (bacteria, fungi, Gram-positive, Gram-negative)
Time Frame: Baseline and up to 3 weeks after intervention
Airborne microbial concentrations, including total bacteria, total fungi, Gram-positive bacteria, and Gram-negative bacteria, will be assessed before and after the use of an air purifier. Unit of Measure: CFU/m³
Change in lung function parameters (SVC, FVC, FEV₁,）
Time Frame: Baseline and up to 3 weeks after intervention
Change in lung volumes including Slow Vital Capacity (SVC), Forced Vital Capacity (FVC), and Forced Expiratory Volume in 1 second (FEV₁) of household members living with preterm infants. Measurements will be taken before and after the intervention. Unit of Measure: Liters (L)
Change in Airflow Rates(MMEF,FEF25,FEF50,FEF75,PEF)
Time Frame: Baseline and up to 3 weeks after intervention
Change in airflow parameters including Maximum Mid-Expiratory Flow (MMEF), Forced Expiratory Flow at 25% (FEF₂₅), 50% (FEF₅₀), and 75% (FEF₇₅) of FVC, and Peak Expiratory Flow (PEF) of household members living with preterm infants. Measurements will be taken before and after the intervention. Unit of Measure: Liters per second (L/s)
Secondary Outcomes
No secondary outcomes reported