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

Recruiting

• Conditions: Chronic Lung Disease of Newborn; Environmental Exposure; Bronchopulmonary Dysplasia

• Registration Number: NCT04107701
• Lead Sponsor: Boston Children's Hospital

Brief 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).

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.

Study Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22
• Primary Completion: 2024-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory Morbidity	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
Lung Function	1 yr	Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better

Secondary Outcome Measures

Name	Time	Method
Lung Function	1 year	FEF25-75 percent predicted units: percent scale: continuous integer, higher is better
Lung function	1 year	Oscillometry Fres units: Hz scale 0 - infinity, lower is better

Trial Locations

Locations (1)

Boston Childrens Hospital; 🇺🇸 Boston, Massachusetts, United States