Premature - Weight 1000g-2499g or Gestation of 28-37weeksNCT07236996
Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge
A study testing air purifier in people with Premature - Weight 1000g-2499g or Gestation of 28-37weeks and Premature Birth, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Birth
- What is being tested?
- air purifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 May 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
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.
- Being tested
- air purifier
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air purifierDevice
air purifier with mechanism of PCO plus three in one filters (Pre-filter/High-Efficiency Activated Carbon/High-Efficiency Particulate Air (HEPA) )
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Air Purifier Intervention and Frequency of Medical Visits | Experimental | Study Arm: Experimental (Air Purifier On) vs. No Intervention (Air Purifier Off） Receives: Device: air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline and up to 3 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start21 May 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature - Weight 1000g-2499g or Gestation of 28-37weeksStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236996
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20210024
- Status last verified
- Apr 2025
- First submitted
- 3 Jul 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge
- ClinicalTrials.gov ID
- NCT07236996
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20210024
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of Air Purifier Intervention and Frequency of Medical Visits | Experimental | Device: air purifierStudy Arm: Experimental (Air Purifier On) vs. No Intervention (Air Purifier Off） |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| air purifierair purifier with mechanism of PCO plus three in one filters (Pre-filter/High-Efficiency Activated Carbon/High-Efficiency Particulate Air (HEPA) ) | Device | Comparison of Air Purifier Intervention and Frequency of Medical Visits |
Primary outcome
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
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
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
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
Related trials for Premature - Weight 1000g-2499g or Gestation of 28-37weeks
Not yet recruiting
Comparison of Two Early Treatments for Premature Babies and Their Effects Over Time
Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Baby 26 to 32 Weeks
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing air purifier in people with Premature - Weight 1000g-2499g or Gestation of 28-37weeks and Premature Birth, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsiu-LIn Chen (+886 0975355876, ch840062@cc.kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in particulate matter concentrations (PM₁, PM₂.₅, PM₄, PM₁₀, TSP) (time frame: Baseline and up to 3 weeks after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.