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

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 Overview

• Status: Recruiting
• Conditions: Premature Birth; Premature - Weight 1000g-2499g or Gestation of 28-37weeks
• Intervention / Treatment: Device: air purifier

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsiu-LIn Chen; Phone Number: +886 0975355876; Email: ch840062@cc.kmu.edu.tw
• Study Contact Backup: Name: Pei-shih Chen; Phone Number: +886 0921813676; Email: pschen@gap.kmu.edu.tw

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • Recruiting
    • Kaohsiung Medical University Chung-Ho Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:Children aged 0 to 6 years who were born at less than 37 weeks of gestation.

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Exclusion Criteria:Children born at more than 37 weeks of gestation.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparison of Air Purifier Intervention and Frequency of Medical Visits; Study Arm: Experimental (Air Purifier On) vs. No Intervention (Air Purifier Off）	Device: air purifier; air purifier with mechanism of PCO plus three in one filters (Pre-filter/High-Efficiency Activated Carbon/High-Efficiency Particulate Air (HEPA) )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Investigative Techniques; Equipment and Supplies; Filtration; Chemistry Techniques, Analytical; Air Filters
• Other Study ID Numbers: KMUHIRB-SV(I)-20210024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No