Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06475976
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia

Eligibility Criteria

Sex
ALL
Age
1 Month - 1 Year
Healthy Volunteers
Not accepted

Interventions

  • Chest computed tomography (CT) with angiography — DIAGNOSTIC_TEST
    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.
  • Bronchoscopy with bronchoalveolar lavage — DIAGNOSTIC_TEST
    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.
  • Echocardiography — DIAGNOSTIC_TEST
    An echo uses sound waves to create computer pictures of the heart.
  • 24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing) — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Dec 5, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Diagnostic cohort
    Study participants will undergo the following diagnostic tests:

Primary Outcome Measure

Empirically defined phenotype subgroup [ Time Frame: Up to 26 months' corrected age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Erik Jensen, MD, MSCE
[email protected]
267-648-2720
Krithika Lingappan, MD, PhD
[email protected]
8324058684

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By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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