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NCT Number: NCT07236996

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.

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Key information

Conditions

Premature - Weight 1000g-2499g or Gestation of 28-37weeks Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

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) )

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Hsiu-LIn Chen

CONTACT

[email protected]

+886 0975355876

Pei-shih Chen

CONTACT

[email protected]

+886 0921813676

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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