Home › Bronchopulmonary Dysplasia › NCT06475976
Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
Who can join
1 Month – 1 Year · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Chest computed tomography (CT) with angiography (diagnostic test)
- Bronchoscopy with bronchoalveolar lavage (diagnostic test)
- Echocardiography (diagnostic test)
- 24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing) (diagnostic test)
Sponsor: Children's Hospital of Philadelphia · Participants: 130 · Started: Dec 5, 2023
Contact the study team
- Erik Jensen, MD, MSCE · Phone: 267-648-2720
- Krithika Lingappan, MD, PhD · Phone: 8324058684
Official record on ClinicalTrials.gov — NCT06475976
Locations in the U.S.
| Pennsylvania | Children's Hospital of Philadelphia, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.