NCT06475976 · Children's Hospital of Philadelphia
Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Empirically defined phenotype subgroup
Time frame: Up to 26 months' corrected age
The number and characteristics of phenotype subgroups will be empirically defined using cluster analyses applied to the collected cardiopulmonary diagnostic and clinical data. All recorded diagnostic and clinical information will be considered for inclusion in these analyses. Final study reports will indicate which diagnostic and clinical data were most associated with cluster classification. The strength of association between assigned cluster and neurodevelopmental and respiratory outcomes assessed through 26 months' corrected age will be defined.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (infant subjects):
- 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
- Parental informed consent (provides the consent to participate)
Exclusion criteria
- (infant subjects):
- 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)
- Aneuploidy or other severe congenital abnormality not-representative in BPD At the time of consent, a parent or guardian caregiver will be invited to participate as an enrolled dyad using the following eligibility criteria: Inclusion criteria (parents/guardians):
- Parent or legal guardian of an enrolled infant subject
- Informed consent Exclusion criteria (parents/guardians):
- Unable/unlikely to complete study procedures
Where
- Philadelphia, Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations