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

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).

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 240

Contacts and Locations

• Study Contact: Name: Jonathan Gaffin, MD. MMSc.; Phone Number: 857-218-5336; Email: jonathan.gaffin@childrens.harvard.edu
• Study Contact Backup: Name: Amparito Cunningham, MD. MPH.; Phone Number: 857-218-5336; Email: amparito.cunningham@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Childrens Hospital
      • Contact: Jonathan Gaffin, MD. MMSc.; Phone Number: 857-218-5336; Email: jonathan.gaffin@childrens.harvard.edu
      • Contact: Amparito Cunningham, MD. MPH.; Phone Number: 8572185336; Email: amparito.cunningham@childrens.harvard.edu
      • Principal Investigator: Jonathan Gaffin, MD. MMSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children 6-12 years with BPD in MA

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lung Function	Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better	1 yr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung function	Oscillometry (R5-20)	1 year
Lung function	Oscillometry (AX) units: cmH20 scale 0 - infinity, lower is better	1 year
Lung function	Oscillometry R5 units: cmH20 scale 0 - infinity, lower is better	1 year
Lung function	Oscillometry R5-20 units: cmH20 scale 0 - infinity, lower is better	1 year
Lung function	Oscillometry X5 units: cmH20 scale 0 - infinity, lower is better	1 year
Lung function	Oscillometry Fres units: Hz scale 0 - infinity, lower is better	1 year
Lung Function	FEV1/FVC units: percent scale: continuous integer, higher is better	1 year
Lung Function	FVC percent predicted units: percent scale: continuous integer, higher is better	1 year
Lung Function	FEF25-75 percent predicted units: percent scale: continuous integer, higher is better	1 year

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Institute of Environmental Health Sciences (NIEHS)
• Investigators: Principal Investigator: Jonathan Gaffin, MD. MMSc., Boston Children's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2019
• Primary Completion (ANTICIPATED): July 31, 2024
• Study Completion (ANTICIPATED): July 31, 2025

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 25, 2019
• First Posted (ACTUAL): September 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: bronchopulmonary dysplasia; BPD; environment; children and environment; bronchopulmonary dysplasia and environment; environment and children; chronic lung disease of newborn; environment and chronic lung disease of the newborn
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Lung Diseases; Bronchopulmonary Dysplasia
• Other Study ID Numbers: P00029918; R01ES030100 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No