Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-1
SponsorChildren's Hospital of Philadelphia

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

130 Participants
are divided into 1 treatment group

Sponsors and collaborators

Children's Hospital of Philadelphia

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator