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Observational Study for Grade 3 Bronchopulmonary Dysplasia

This study is looking at infants with severe Bronchopulmonary Dysplasia (BPD), a chronic lung disease that affects babies born too early. The goal is to better understand different types of severe BPD by looking at various diagnostic tests. These tests include a Chest computed tomography (CT) scan (a special X-ray), Bronchoscopy with bronchoalveolar lavage (looking into the lungs with a small camera and collecting fluid), Echocardiography (an ultrasound of the heart), and 24-hour esophageal pH monitoring (to check for reflux). Researchers hope to find different groups of BPD based on these tests and see how these groups relate to a child's development and breathing up to 26 months of age. This study is for infants between 1 month and 1 year old who were born before 32 weeks of pregnancy and are currently on a ventilator with severe BPD.

Study design
This is an observational study, meaning researchers will gather information without giving new treatments. It plans to enroll 130 participants.
What's involved
Participants will undergo several diagnostic tests including a CT scan, bronchoscopy, echocardiogram, and 24-hour pH monitoring.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure outcomes up to 26 months' corrected age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06475976

Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Recruiting
Not specifiedAges 1–1Observational
Children's Hospital of Philadelphia
~130 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Chest computed tomography (CT) with angiographyBronchoscopy with bronchoalveolar lavageEchocardiography24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Empirically defined phenotype subgroup
Measured over Up to 26 months' corrected age

Conditions

Bronchopulmonary Dysplasia

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Bronchopulmonary Dysplasia

NCT06475976

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Erik Jensen, MD, MSCE · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
  • Krithika Lingappan, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Erik Jensen, MD, MSCE
[email protected]
267-648-2720
Email the study team

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Eligibility criteria

Inclusion

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)
Parent or legal guardian of an enrolled infant subject
Informed consent

Exclusion

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
Unable/unlikely to complete study procedures

What this trial measures

  • Empirically defined phenotype subgroupUp 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.