Recruiting

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06475976

Conditions

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

Chest computed tomography (CT) with angiography

Bronchoscopy with bronchoalveolar lavage

Echocardiography

24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing)

Study Details

Brief 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.

Conditions

Bronchopulmonary Dysplasia

Study ID

NCT06475976

Start date

Dec 5, 2023

Status verified date

Jul, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

Arms

Diagnostic cohort

Study participants will undergo the following diagnostic tests:

Interventions

Chest computed tomography (CT) with angiography

A CT scan uses a doughnut-shaped machine to take x-rays in a circle around the body. CT scans help doctors learn about the structure of the lungs, heart, and blood vessels in the chest. A CT scan provides more information than regular x-rays. CT w/angiography - injection of intravenous contrast during the CT to image the blood vessels within the chest.

Bronchoscopy with bronchoalveolar lavage

During a bronchoscopy, a lung doctor inserts a small flexible camera into the breathing tube and main branches of the airways within the lungs. During the test, a small amount of sterile fluid is placed into the lung and then retrieved (lavage). This fluid is tested for evidence of infection.

Echocardiography

An echo uses sound waves to create computer pictures of the heart.

24 hour esophageal pH ("potential of hydrogen") - multichannel intraluminal impedance (MII) monitoring (reflux testing)

24 hour pH/MII testing is used to measure gastroesophageal reflux. A small feeding tube like catheter is passed through the nose or mouth into the esophagus. The catheter is used to measure the frequency and acidity of reflux episodes during a 24 hour monitoring period.

Primary outcome measure

  • Empirically defined phenotype subgroup [ Time Frame: Up to 26 months' corrected age ]

Central Contacts and Locations

Central contacts

Erik Jensen, MD, MSCE

267-648-2720jensene@chop.edu

Krithika Lingappan, MD, PhD

8324058684lingappank@chop.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erik Jensen, MD, MSCE

267-648-2720jensene@chop.edu

Krithika Lingappan, MD, PhD

8324058684lingappank@chop.edu

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • Bronchopulmonary Dysplasia
  • BPD
  • Multidimensional Phenotype

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-07-28.