Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
United States130 participantsStarted 2023-12-05
Plain-language 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
Age range
1 Month – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.