Clinical trial NCT04107701: Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD
Official title: Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2019-09-27
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 6-12 years with BPD in MA

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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Morbidity
timeFrame: 2 weeks
measure: Lung Function
timeFrame: 1 yr
Secondary outcomes:
measure: Lung function
timeFrame: 1 year
measure: Lung function
timeFrame: 1 year
measure: Lung function
timeFrame: 1 year
measure: Lung function
timeFrame: 1 year
measure: Lung function
timeFrame: 1 year
measure: Lung function
timeFrame: 1 year
measure: Lung Function
timeFrame: 1 year
measure: Lung Function
timeFrame: 1 year
measure: Lung Function
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jonathan Gaffin, MD. MMSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.