Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
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), t
| Condition(s) | Bronchopulmonary Dysplasia |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 en |
| Ages | 1 Month to 1 Year |
| Sex | All |
| Lead sponsor | Children's Hospital of Philadelphia |
| Locations | Philadelphia, Pennsylvania, United States |
| Start date | 2023-12-05 |
| NCT ID | NCT06475976 |
| Official listing | https://clinicaltrials.gov/study/NCT06475976 |