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

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ClinicalTrials.gov Identifier: NCT04107701
Recruitment Status : Recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Jonathan M. Gaffin, 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).

Condition or disease
Bronchopulmonary Dysplasia Chronic Lung Disease of Newborn Environmental Exposure

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.

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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Other
Time Perspective: Other
Official Title: Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Respiratory Morbidity [ Time Frame: 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

  2. Lung Function [ Time Frame: 1 yr ]
    Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better


Secondary Outcome Measures :
  1. Lung function [ Time Frame: 1 year ]
    Oscillometry (R5-20)

  2. Lung function [ Time Frame: 1 year ]
    Oscillometry (AX) units: cmH20 scale 0 - infinity, lower is better

  3. Lung function [ Time Frame: 1 year ]
    Oscillometry R5 units: cmH20 scale 0 - infinity, lower is better

  4. Lung function [ Time Frame: 1 year ]
    Oscillometry R5-20 units: cmH20 scale 0 - infinity, lower is better

  5. Lung function [ Time Frame: 1 year ]
    Oscillometry X5 units: cmH20 scale 0 - infinity, lower is better

  6. Lung function [ Time Frame: 1 year ]
    Oscillometry Fres units: Hz scale 0 - infinity, lower is better

  7. Lung Function [ Time Frame: 1 year ]
    FEV1/FVC units: percent scale: continuous integer, higher is better

  8. Lung Function [ Time Frame: 1 year ]
    FVC percent predicted units: percent scale: continuous integer, higher is better

  9. Lung Function [ Time Frame: 1 year ]
    FEF25-75 percent predicted units: percent scale: continuous integer, higher is better



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children 6-12 years with BPD in MA
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107701


Contacts
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Contact: Jonathan Gaffin, MD. MMSc. 857-218-5336 jonathan.gaffin@childrens.harvard.edu
Contact: Amparito Cunningham, MD. MPH. 857-218-5336 amparito.cunningham@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Childrens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jonathan Gaffin, MD. MMSc.    857-218-5336    jonathan.gaffin@childrens.harvard.edu   
Contact: Amparito Cunningham, MD. MPH.    8572185336    amparito.cunningham@childrens.harvard.edu   
Principal Investigator: Jonathan Gaffin, MD. MMSc.         
Sponsors and Collaborators
Boston Children's Hospital
National Institute of Environmental Health Sciences (NIEHS)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jonathan M. Gaffin, Principal Investigator, Assistant Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04107701    
Other Study ID Numbers: P00029918
R01ES030100 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan M. Gaffin, Boston Children's Hospital:
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
Additional relevant MeSH terms:
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Lung Diseases
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases