Evaluation of the Health Effects of the Air Purifier in Preterm Infants After Discharge
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: air purifier.
- Who it may be relevant to
- Registry conditions: Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Premature Birth. Basic parameters: up to 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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) )
Primary outcome measures
- Change in particulate matter concentrations (PM₁, PM₂.₅, PM₄, PM₁₀, TSP) [Time frame: Baseline and up to 3 weeks after intervention]
- Change in gaseous pollutant concentrations (CH₂O, NO₂, CO, SO₂, VOC, CO₂) [Time frame: Baseline and up to 3 weeks after intervention]
- Change in microbial concentrations (bacteria, fungi, Gram-positive, Gram-negative) [Time frame: Baseline and up to 3 weeks after intervention]
- Change in lung function parameters (SVC, FVC, FEV₁,） [Time frame: Baseline and up to 3 weeks after intervention]
- Change in Airflow Rates(MMEF,FEF25,FEF50,FEF75,PEF) [Time frame: Baseline and up to 3 weeks after intervention]
Eligibility criteria
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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
Identifiers
NCT: NCT07236996 · KMUHIRB-SV(I)-20210024