Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04107701
Other study ID # P00029918
Secondary ID R01ES030100
Status Recruiting
Phase
First received
Last updated
Start date July 22, 2019
Est. completion date July 31, 2025

Study information

Verified date September 2022
Source Boston Children's Hospital
Contact Jonathan Gaffin, MD. MMSc.
Phone 857-218-5336
Email jonathan.gaffin@childrens.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date July 31, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Locations

Country Name City State
United States Boston Childrens Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Boston Children's Hospital National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Lung Function Spirometry (FEV1 percent predicted) Units: percent Scale: continuous integers, higher is better 1 yr
Secondary Lung function Oscillometry (R5-20) 1 year
Secondary Lung function Oscillometry (AX) units: cmH20 scale 0 - infinity, lower is better 1 year
Secondary Lung function Oscillometry R5 units: cmH20 scale 0 - infinity, lower is better 1 year
Secondary Lung function Oscillometry R5-20 units: cmH20 scale 0 - infinity, lower is better 1 year
Secondary Lung function Oscillometry X5 units: cmH20 scale 0 - infinity, lower is better 1 year
Secondary Lung function Oscillometry Fres units: Hz scale 0 - infinity, lower is better 1 year
Secondary Lung Function FEV1/FVC units: percent scale: continuous integer, higher is better 1 year
Secondary Lung Function FVC percent predicted units: percent scale: continuous integer, higher is better 1 year
Secondary Lung Function FEF25-75 percent predicted units: percent scale: continuous integer, higher is better 1 year
See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A