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

Bronchopulmonary Dysplasia Clinical Trial

— AeroBPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107701
• Other study ID #: P00029918
• Secondary ID: R01ES030100
• Status: Recruiting
• Start date: July 22, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: September 2022
• Source: Boston Children's Hospital
• Contact: Jonathan Gaffin, MD. MMSc.
• Phone: 857-218-5336
• Email: jonathan.gaffin[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Boston Childrens Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Primary	Lung Function	Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better	1 yr
Secondary	Lung function	Oscillometry (R5-20)	1 year
Secondary	Lung function	Oscillometry (AX) units: cmH20 scale 0 - infinity, lower is better	1 year
Secondary	Lung function	Oscillometry R5 units: cmH20 scale 0 - infinity, lower is better	1 year
Secondary	Lung function	Oscillometry R5-20 units: cmH20 scale 0 - infinity, lower is better	1 year
Secondary	Lung function	Oscillometry X5 units: cmH20 scale 0 - infinity, lower is better	1 year
Secondary	Lung function	Oscillometry Fres units: Hz scale 0 - infinity, lower is better	1 year
Secondary	Lung Function	FEV1/FVC units: percent scale: continuous integer, higher is better	1 year
Secondary	Lung Function	FVC percent predicted units: percent scale: continuous integer, higher is better	1 year
Secondary	Lung Function	FEF25-75 percent predicted units: percent scale: continuous integer, higher is better	1 year