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

Recruiting

• Conditions: Bronchopulmonary Dysplasia

• Registration Number: NCT05285345
• Lead Sponsor: Boston Children's Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-17
• Study Start: 2023-09-27
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthcare Utilization	8 months	Review of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.

Secondary Outcome Measures

Name	Time	Method
Medication use	8 months	Review of medical record
Rates of pulmonary follow-up and use of telemedicine in follow-up	8 months	Review of medical record
Family satisfaction with care for respiratory symptoms around and after discharge	8 months	Assessed by surveys
Completion of recommended evaluations and testing	8 months	Review of medical record
Home oxygen use	8 months	Review of medical record
Feeding	8 months	Review of medical record

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States