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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285345
• Other study ID #: IRB-P00039393
• Status: Recruiting
• Start date: September 27, 2023
• Est. completion date: November 2025

Study information

• Verified date: November 2023
• Source: Boston Children's Hospital
• Contact: Jonathan Levin, MD
• Phone: 617-355-1900
• Email: jonathan.levin[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 1 Year

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Lung Diseases

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Children's Hospital	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healthcare Utilization	Review of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.	8 months
Secondary	Rates of pulmonary follow-up and use of telemedicine in follow-up	Review of medical record	8 months
Secondary	Completion of recommended evaluations and testing	Review of medical record	8 months
Secondary	Medication use	Review of medical record	8 months
Secondary	Home oxygen use	Review of medical record	8 months
Secondary	Feeding	Review of medical record	8 months
Secondary	Family satisfaction with care for respiratory symptoms around and after discharge	Assessed by surveys	8 months