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CompletedNCT04107701AeroBPDUpdated May 6, 2026

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

An observational study in Bronchopulmonary Dysplasia, Chronic Lung Disease of Newborn and Environmental Exposure, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Boston Children's Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
165
Ages
6 Years to 12 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Bronchopulmonary Dysplasia
  • Chronic Lung Disease of Newborn
  • Environmental Exposure

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
03

In context

Bronchopulmonary Dysplasia

339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.

This study's enrollment of 165 is above the median of 137 across 92 observational studies indexed under Bronchopulmonary Dysplasia.

Browse Bronchopulmonary Dysplasia studies →

Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children 6-12 years with BPD in MA

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

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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
165 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

    Time frame: 2 weeks

  2. Lung Function

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

    Time frame: 1 yr

Secondary outcomes

  1. Lung function

    Oscillometry (R5-20)

    Time frame: 1 year

  2. Lung function

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

    Time frame: 1 year

  3. Lung function

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

    Time frame: 1 year

  4. Lung function

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

    Time frame: 1 year

  5. Lung function

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

    Time frame: 1 year

  6. Lung function

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

    Time frame: 1 year

  7. Lung Function

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

    Time frame: 1 year

  8. Lung Function

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

    Time frame: 1 year

  9. Lung Function

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

    Time frame: 1 year

07

Study locations

1 site
  • Boston Childrens Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04107701
Lead sponsor
Boston Children's Hospital
Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Responsible party
Jonathan M. Gaffin (Principal Investigator, Assistant Professor of Pediatrics, Boston Children's Hospital) — Principal investigator
First posted
Sep 27, 2019
Start date
Jul 22, 2019
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
May 6, 2026

Study contacts

Jonathan Gaffin, MD. MMSc.
principal investigator · Boston Children's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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