Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05285345

Conditions

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. This study looks to evaluate implementation of the recommendations at Boston Children's Hospital and referring NICU's (Beth Israel Deaconess Medical Center and Brigham and Women's Hospital). Specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction/feedback with implementation of these guidelines.

Conditions

Bronchopulmonary Dysplasia

Study ID

NCT05285345

Start date

Sep 27, 2023

Status verified date

May, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Preterm infants born <32 weeks with at least mild BPD, defined as 28 days of respiratory support after birth.
  • Efforts will be made to include a mix of infants with mild, moderate, and severe BPD, including infants discharged on oxygen.

Exclusion Criteria:

  • Discharge to a location other than home.
  • Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Pre-Guideline Implementation

Participants in this group will be recruited during the first 3 months of the study and the time will be used for baseline data collection with existing standards of care around discharge practices of infants with BPD

Post-Guideline Implementation

After 3 months, the discharge bundle developed from consensus from the Delphi process will be introduced to both NICUs using Quality Improvement principles. Participants will be recruited after the introduction of the discharge bundle.

Primary outcome measure

  • Healthcare Utilization [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Jonathan Levin, MD

617-355-1900jonathan.levin@childrens.harvard.edu

Vanessa J Young

617-355-8330vanessa.young@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jonathan Levin, MD

617-335-1900jonathan.levin@childrens.harvard.edu

More Information

Sponsor

Boston Children's Hospital

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Bronchopulmonary Dysplasia
  • NICU Discharge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-06-02.