Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease

NCT ID: NCT05285345

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-27
• Study Completion Date: 2025-11-30

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.

Detailed Description

Premature infants with bronchopulmonary dysplasia (BPD) have complex care needs around discharge. BPD affects up to 40% of former preterm infants born at <28 weeks gestation, with about 10,000 new cases of BPD in the United States every year. Healthcare utilization in this population in the first two years of life is high, with increased hospitalizations, visits, and medication usage. Coordinated follow-up programs may help improve outcomes and reduce rates of hospitalization in this population. However, guidelines do not exist to identify which infants discharging from the NICU should be targeted for specialty follow-up for their respiratory disease, the time frame and format that this should occur, and which evaluations should be performed routinely around discharge.

This will be an implementation study, measuring outcomes 3 months prior and 3 months after enactment of a discharge bundle for preterm infants with BPD at local NICUs (Brigham and Women's Hospital, Beth Israel Deaconess Medical Center) who will be followed by Boston Children's Hospital.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Levin

Instructor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Levin, MD

Role: CONTACT

jonathan.levin@childrens.harvard.edu

617-355-1900

Vanessa J Young

Role: CONTACT

vanessa.young@childrens.harvard.edu

617-355-8330

Facility Contacts

Jonathan Levin, MD

Role: primary

jonathan.levin@childrens.harvard.edu

617-335-1900

Other Identifiers

IRB-P00039393

Identifier Type: -

Identifier Source: org_study_id