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NCT Number: NCT04107701

Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD

Investigators want to learn the role of indoor environmental exposures on respiratory symptoms, and, separately, on lung function deficits in school-aged children with bronchopulmonary dysplasia (BPD).

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

About this study

Bronchopulmonary dysplasia (BPD) is the most common respiratory disease affecting children born prematurely and leads to long-term respiratory symptoms and lung function impairment throughout childhood. This study will, evaluate the contribution of indoor sources of respiratory irritants to respiratory health impairment in school-aged children with BPD. State-of-the-art measures of indoor air quality constituents will assess the relationship of nitrogen dioxide (NO2), particulate matter (PM2.5), as well as, concentrations of allergens (mold, mouse, cockroach, pet), endotoxin, air temperature and humidity with concurrently measured respiratory symptoms and lung function in a well-characterized cohort of children with BPD. This research will identify specific harmful components of the indoor environment associated with respiratory morbidity and poor lung function in children with BPD.

Investigators will ask the participants to come in for a one time clinic visit for undergoing procedures as well as answering questions regarding health and home environment. During the 1 year of participation there will also be 2 home assessment visits where investigators will take a sample of the home environment as well record home characteristics.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children 6-12 yrs old
  • born <32 wks gestational age
  • diagnosis of BPD or > 28 days of oxygen or respiratory support

Exclusion criteria

  • major airway or chest surgery
  • physical or mental impairment that will prevent from doing spirometry
  • plans to move out of state within the next 9 months

Treatment and study plan

Primary outcomes

  1. Respiratory Morbidity

    Time frame: 2 weeks

    maximum symptom days in the prior 2 weeks assessed at completion of home sampling visits ( Units: days scale: 0-14 days with symptoms, higher is worse

  2. Lung Function

    Time frame: 1 yr

    Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better

Secondary outcomes

  1. Lung function

    Time frame: 1 year

    Oscillometry (R5-20)

  2. Lung function

    Time frame: 1 year

    Oscillometry (AX) units: cmH20 scale 0 - infinity, lower is better

  3. Lung function

    Time frame: 1 year

    Oscillometry R5 units: cmH20 scale 0 - infinity, lower is better

  4. Lung function

    Time frame: 1 year

    Oscillometry R5-20 units: cmH20 scale 0 - infinity, lower is better

  5. Lung function

    Time frame: 1 year

    Oscillometry X5 units: cmH20 scale 0 - infinity, lower is better

  6. Lung function

    Time frame: 1 year

    Oscillometry Fres units: Hz scale 0 - infinity, lower is better

  7. Lung Function

    Time frame: 1 year

    FEV1/FVC units: percent scale: continuous integer, higher is better

  8. Lung Function

    Time frame: 1 year

    FVC percent predicted units: percent scale: continuous integer, higher is better

  9. Lung Function

    Time frame: 1 year

    FEF25-75 percent predicted units: percent scale: continuous integer, higher is better

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

Registry information

Acronym: AeroBPD

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2019
Registry last updated
May 6, 2026

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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