RecruitingNCT06475976

Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Sponsor

Children's Hospital of Philadelphia

Enrollment

130 participants

Start Date

Dec 5, 2023

Study Type

OBSERVATIONAL

Conditions

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.

Eligibility

Min Age: 1 MonthMax Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing), Bronchoscopy with bronchoalveolar lavage, and others for people with bronchopulmonary dysplasia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 1 Month to 1 Year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTChest 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_TESTBronchoscopy 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_TESTEchocardiography

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

DIAGNOSTIC_TEST24 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.