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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05285345
Enrollment
50
Registered
2022-03-17
Start date
2023-09-27
Completion date
2027-11-01
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

Bronchopulmonary Dysplasia, NICU Discharge

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.

Interventions

None listed

Sponsors

Boston Children's Hospital
Lead SponsorOTHER
Beth Israel Deaconess Medical Center
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 1 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Healthcare Utilization8 monthsReview of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.

Secondary

MeasureTime frameDescription
Rates of pulmonary follow-up and use of telemedicine in follow-up8 monthsReview of medical record
Completion of recommended evaluations and testing8 monthsReview of medical record
Medication use8 monthsReview of medical record
Home oxygen use8 monthsReview of medical record
Feeding8 monthsReview of medical record
Family satisfaction with care for respiratory symptoms around and after discharge8 monthsAssessed by surveys

Countries

United States

Contacts

CONTACTJonathan Levin, MD
jonathan.levin@childrens.harvard.edu617-355-1900
CONTACTVanessa J Young
vanessa.young@childrens.harvard.edu617-355-8330
PRINCIPAL_INVESTIGATORJonathan Levin, MD

Boston Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026