Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1
Healthy Volunteers: f
View:

• 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)

• Parent or legal guardian of an enrolled infant subject

• Informed consent

Locations
United States
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Erik Jensen, MD, MSCE
jensene@chop.edu
267-648-2720
Backup
Krithika Lingappan, MD, PhD
lingappank@chop.edu
8324058684
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 130
Treatments
Diagnostic cohort
Study participants will undergo the following diagnostic tests:
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov