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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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) )

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Comparison of Air Purifier Intervention and Frequency of Medical VisitsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and up to 3 weeks after intervention
2

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

Time frame
Baseline and up to 3 weeks after intervention
3

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

Time frame
Baseline and up to 3 weeks after intervention
4

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)

Time frame
Baseline and up to 3 weeks after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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