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

NCT ID: NCT04107701

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-22

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia Chronic Lung Disease of Newborn Environmental Exposure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonathan M. Gaffin

Principal Investigator, Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Gaffin, MD. MMSc.

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Childrens Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan Gaffin, MD. MMSc.

Role: CONTACT

857-218-5336

Amparito Cunningham, MD. MPH.

Role: CONTACT

857-218-5336

Facility Contacts

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Jonathan Gaffin, MD. MMSc.

Role: primary

857-218-5336

Amparito Cunningham, MD. MPH.

Role: backup

8572185336

References

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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.

Reference Type DERIVED
PMID: 34193433 (View on PubMed)

Other Identifiers

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R01ES030100

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P00029918

Identifier Type: -

Identifier Source: org_study_id

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