Classification of severe bronchopulmonary dysplasia in infants
Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
This study is trying to create a new way to classify the most severe form of bronchopulmonary dysplasia in infants to see how different types of the condition affect their breathing and brain development over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 1 Month to 1 Year |
| Sex | All |
| Sponsor | Children's Hospital of Philadelphia Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06475976 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on infants diagnosed with grade 3 bronchopulmonary dysplasia (BPD), the most severe form of this chronic lung disease. It aims to create an empirically defined classification system for grade 3 BPD using a variety of objective cardiopulmonary diagnostic, clinical, and biological data. The study will also explore the relationship between different phenotype subgroups and their neurodevelopmental and respiratory outcomes up to two years of corrected age. By employing advanced diagnostic technologies, the study seeks to better characterize disease heterogeneity and improve outcome predictions for affected infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born with a gestational age of less than 32 weeks who are receiving invasive ventilation and have been diagnosed with grade 3 BPD.
Not a fit: Patients who are unlikely to survive the diagnostic period or have severe congenital abnormalities not representative of BPD may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, phenotype-targeted therapies for infants with severe bronchopulmonary dysplasia.
How similar studies have performed: While the approach of multidimensional phenotyping is novel in the context of grade 3 BPD, similar methodologies have shown success in other heterogeneous lung diseases.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Erik Jensen, MD, MSCE — Children's Hospital of Philadelphia
- Study coordinator: Erik Jensen, MD, MSCE
- Email: jensene@chop.edu
- Phone: 267-648-2720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.