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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jonathan Levin, MD; Phone Number: 617-355-1900; Email: jonathan.levin@childrens.harvard.edu
• Study Contact Backup: Name: Vanessa J Young; Phone Number: 617-355-8330; Email: vanessa.young@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Jonathan Levin, MD; Phone Number: 617-335-1900; Email: jonathan.levin@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital
• Investigators: Principal Investigator: Jonathan Levin, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Bronchopulmonary Dysplasia; NICU Discharge
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchopulmonary Dysplasia
• Other Study ID Numbers: IRB-P00039393

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No