Classification of severe bronchopulmonary dysplasia in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lung Ultrasound Score to predict BPD in very preterm babies

  This study tests whether lung ultrasound scores in the first two weeks of life can predict which extremely preterm babies will develop bronchopulmonary dysplasia.

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• IVIG for bronchopulmonary dysplasia in infants born at 28 weeks or earlier

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• High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies

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  Recruiting Phase 1/2 University of Alabama at Birmingham · Birmingham, Alabama · NCT07307612

• Reduced versus higher daily fluids to prevent bronchopulmonary dysplasia in very preterm babies

  This tests whether giving smaller daily fluid volumes from day 8 of life (about 135 mL/kg/day) instead of larger volumes (about 165 mL/kg/day) lowers the chance of developing BPD or dying before 36 weeks in babies born before 30 weeks.

  Recruiting at 9 sites University Children's Hospital Basel · Aarau and 8 other locations · NCT06954142

• Using IVIG to treat bronchopulmonary dysplasia in premature infants

  This study is testing if a special immune treatment called IVIG can help premature babies with breathing problems caused by bronchopulmonary dysplasia feel better.

  Recruiting Phase 2 International Peace Maternity and Child Health Hospital · Shanghai, Shanghai Municipality · NCT06925360

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.