NCT06475976 Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
| NCT ID | NCT06475976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Bronchopulmonary Dysplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 130 participants in total. It began in 2023-12-05 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Erik Jensen, MD, MSCE
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT06475976 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 1 Year, studying Bronchopulmonary Dysplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06475976 currently recruiting?
Yes, NCT06475976 is actively recruiting participants. Contact the research team at jensene@chop.edu for enrollment information.
Where is the NCT06475976 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06475976 clinical trial?
NCT06475976 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Erik Jensen, MD, MSCE at Children's Hospital of Philadelphia. The trial plans to enroll 130 participants.