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

NCT07236996 | Recruiting

• 1 other identifier: KMUHIRB-SV(I)-20210024
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Change in particulate matter concentrations (PM₁, PM₂.₅, PM₄, PM₁₀, TSP)

  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

  Baseline and up to 3 weeks after intervention

• Change in gaseous pollutant concentrations (CH₂O, NO₂, CO, SO₂, VOC, CO₂)

  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

  Baseline and up to 3 weeks after intervention

• Change in microbial concentrations (bacteria, fungi, Gram-positive, Gram-negative)

  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

  Baseline and up to 3 weeks after intervention

• Change in lung function parameters (SVC, FVC, FEV₁,）

  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)

  Baseline and up to 3 weeks after intervention

• Change in Airflow Rates(MMEF,FEF25,FEF50,FEF75,PEF)

  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)

  Baseline and up to 3 weeks after intervention

Study Arms (1)

Comparison of Air Purifier Intervention and Frequency of Medical Visits

EXPERIMENTAL

Study Arm: Experimental (Air Purifier On) vs. No Intervention (Air Purifier Off）

Device: air purifier

Interventions

air purifier DEVICE

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

Comparison of Air Purifier Intervention and Frequency of Medical Visits

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Central Study Contacts

Hsiu-LIn Chen

CONTACT

+886 0975355876; ch840062@cc.kmu.edu.tw

Pei-shih Chen

CONTACT

+886 0921813676; pschen@gap.kmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: November 19, 2025
• Study Start: May 21, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-04

Locations

TW (1)