NCT04107701

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

6.4 years

First QC Date

September 24, 2019

Last Update Submit

May 5, 2026

Conditions

Bronchopulmonary DysplasiaChronic Lung Disease of NewbornEnvironmental Exposure

Keywords

BPDbronchopulmonary dysplasiachildren and environmentenvironmentbronchopulmonary dysplasia and environmentenvironment and childrenchronic lung disease of newbornenvironment and chronic lung disease of the newborn

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Lung function

    1 year

  • Lung function

    1 year

  • Lung function

    1 year

  • Lung function

    1 year

  • Lung function

    1 year

  • +4 more secondary outcomes

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 6-12 years with BPD in MA

You may qualify if:

  • children 6-12 yrs old
  • born \<32 wks gestational age
  • diagnosis of BPD or \> 28 days of oxygen or respiratory support

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 34193433DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jonathan Gaffin, MD. MMSc.

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor of Pediatrics

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 27, 2019

Study Start

July 22, 2019

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)