AzTrials
AzTrials

Bronchopulmonary DysplasiaAeroBPDNCT04107701

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

An observational study of Bronchopulmonary Dysplasia and Chronic Lung Disease of Newborn, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 6 to 12 years
How many people
165 participants
Where
1 siteUnited States
Study dates
22 Jul 2019to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children 6-12 years with BPD in MA

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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).

Read the detailed description

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.

Keywords
BPD, bronchopulmonary dysplasia, children and environment, environment, bronchopulmonary dysplasia and environment, environment and children, chronic lung disease of newborn, environment and chronic lung disease of the newborn
Medical subject headings
Bronchopulmonary Dysplasia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory Morbidity

    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

    Measured: 2 weeks

  2. Lung Function

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

    Measured: 1 yr

Secondary outcomes (9)

  1. Lung function

    Oscillometry (R5-20)

    Measured: 1 year

  2. Lung function

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

    Measured: 1 year

  3. Lung function

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

    Measured: 1 year

  4. Lung function

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

    Measured: 1 year

  5. Lung function

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

    Measured: 1 year

  6. Lung function

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

    Measured: 1 year

  7. Lung Function

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

    Measured: 1 year

  8. Lung Function

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

    Measured: 1 year

  9. Lung Function

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start22 Jul 2019
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04107701
Sponsor's protocol ID
P00029918
Other IDs
R01ES030100
Acronym
AeroBPD
Status last verified
May 2026
First submitted
24 Sep 2019
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ruran HB, Adamkiewicz G, Cunningham A, Petty CR, Greco KF, Gunnlaugsson S, Stamatiadis N, Sierra G, Vallarino J, Alvarez M, Hayden LP, Sheils CA, Weller E, Phipatanakul W, Gaffin JM. Air quality, Environment and Respiratory Outcomes in Bronchopulmonary Dysplasia, the AERO-BPD cohort study: design and adaptation during the SARS-CoV-2 pandemic. BMJ Open Respir Res. 2021 Jun;8(1):e000915. doi: 10.1136/bmjresp-2021-000915.

    PubMed 34193433

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchopulmonary Dysplasia and Chronic Lung Disease of Newborn, run by Boston Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 6 May 2026. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Morbidity (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107701, which also lists 1 linked publication.

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 6 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in