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Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Recruitingn/aAges 1 Month - 1 YearAllChildren's Hospital of Philadelphia
NCT06475976 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Chest computed tomography (CT) with angiography
  • Bronchoscopy with bronchoalveolar lavage
  • Echocardiography
  • 24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing)
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Where

1 site
Children's Hospital of Philadelphia
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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