About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Chest computed tomography (CT) with angiography
- Bronchoscopy with bronchoalveolar lavage
- Echocardiography
- 24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing)
Treatment groups
Sponsors and collaborators
Children's Hospital of Philadelphia
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator