Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
Children's Hospital of Philadelphia
130 participants
Dec 5, 2023
OBSERVATIONAL
Conditions
Summary
Bronchopulmonary Dysplasia (BPD), or chronic lung disease of prematurity, is the most consequential complication of preterm birth and is strong predictor of childhood pulmonary and neurodevelopmental disability, particularly in infants diagnosed with grade 3 BPD (ventilator dependence at 36 weeks' postmenstrual age), the most severe disease form. This study aims to (1) generate the first empirically defined phenotype classification system for grade 3 BPD developed using a rich array of objective and quantitative cardiopulmonary diagnostic, clinical, and biological data; and (2) define the association between phenotype subgroups and neurodevelopmental and respiratory outcomes through 2 years' corrected age.
Eligibility
Inclusion Criteria7
- Male or female infant born with gestational age <32 weeks
- Postmenstrual age between 36-65 weeks at enrollment
- Receiving invasive ventilation at enrollment
- Grade 3 BPD or grade 2 BPD with need for chronic invasive ventilation at enrollment
- Parental informed consent (provides the consent to participate)
- Parent or legal guardian of an enrolled infant subject
- Informed consent
Exclusion Criteria7
- Contraindication to 1 or more of the study diagnostic procedures
- Family unable/unlikely to commit to 2-year follow-up
- Unlikely to survive the 6-8-week diagnostic period
- Parental consent not provided (decline consenting for study)
- Aneuploidy or other severe congenital abnormality not-representative in BPD
- At the time of consent, a parent or guardian caregiver will be invited to participate as an enrolled dyad using the following eligibility criteria:
- Unable/unlikely to complete study procedures
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
A CT scan uses a doughnut-shaped machine to take x-rays in a circle around the body. CT scans help doctors learn about the structure of the lungs, heart, and blood vessels in the chest. A CT scan provides more information than regular x-rays. CT w/angiography - injection of intravenous contrast during the CT to image the blood vessels within the chest.
During a bronchoscopy, a lung doctor inserts a small flexible camera into the breathing tube and main branches of the airways within the lungs. During the test, a small amount of sterile fluid is placed into the lung and then retrieved (lavage). This fluid is tested for evidence of infection.
An echo uses sound waves to create computer pictures of the heart.
24 hour pH/MII testing is used to measure gastroesophageal reflux. A small feeding tube like catheter is passed through the nose or mouth into the esophagus. The catheter is used to measure the frequency and acidity of reflux episodes during a 24 hour monitoring period.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06475976