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

NCT05285345 | Recruiting

• 1 other identifier: IRB-P00039393
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

Bronchopulmonary Dysplasia; NICU Discharge

Outcome Measures

Primary Outcomes (1)

• Healthcare Utilization

  Review of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.

  8 months

Secondary Outcomes (6)

• Rates of pulmonary follow-up and use of telemedicine in follow-up

  8 months

• Completion of recommended evaluations and testing

  8 months

• Medication use

  8 months

• Home oxygen use

  8 months

• Feeding

  8 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jonathan Levin, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Levin, MD

CONTACT

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

Vanessa J Young

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Pediatrics

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: September 27, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Locations

US (1)