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Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge

Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07236996
Enrollment
180
Registered
2025-11-19
Start date
2021-05-21
Completion date
2026-06-30
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth, Premature - Weight 1000g-2499g or Gestation of 28-37weeks

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.

Interventions

air purifier with mechanism of PCO plus three in one filters (Pre-filter/High-Efficiency Activated Carbon/High-Efficiency Particulate Air (HEPA) )

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
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. \-

Design outcomes

Primary

MeasureTime frameDescription
Change in particulate matter concentrations (PM₁, PM₂.₅, PM₄, PM₁₀, TSP)Baseline and up to 3 weeks after interventionIndoor 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)Baseline and up to 3 weeks after interventionIndoor 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)Baseline and up to 3 weeks after interventionAirborne 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,)Baseline and up to 3 weeks after interventionChange 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)Baseline and up to 3 weeks after interventionChange 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)

Countries

Taiwan

Contacts

Primary ContactHsiu-LIn Chen
ch840062@cc.kmu.edu.tw+886 0975355876
Backup ContactPei-shih Chen
pschen@gap.kmu.edu.tw+886 0921813676

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026