Clinical trial NCT05285345: Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Official title: Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
NICU Discharge
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
First posted: 2022-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Healthcare Utilization
timeFrame: 8 months
Secondary outcomes:
measure: Rates of pulmonary follow-up and use of telemedicine in follow-up
timeFrame: 8 months
measure: Completion of recommended evaluations and testing
timeFrame: 8 months
measure: Medication use
timeFrame: 8 months
measure: Home oxygen use
timeFrame: 8 months
measure: Feeding
timeFrame: 8 months
measure: Family satisfaction with care for respiratory symptoms around and after discharge
timeFrame: 8 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jonathan Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: