Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

DIAGNOSTIC_TEST

Chest computed tomography (CT) with angiography

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.

DIAGNOSTIC_TEST

Bronchoscopy with bronchoalveolar lavage

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.

DIAGNOSTIC_TEST

Echocardiography

An echo uses sound waves to create computer pictures of the heart.

DIAGNOSTIC_TEST

24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing)

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Children's Hospital of Philadelphia

  lead OTHER

Principal Investigators

• Erik Jensen, MD, MSCE · Children's Hospital of Philadelphia

• Krithika Lingappan, MD, PhD · Children's Hospital of Philadelphia

Eligibility

Min Age

1 Month

Max Age

1 Year

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-12-05

Primary Completion

2028-12-31

Completion

2029-07-31

Countries

• United States

Study Locations