Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia. Basic parameters: 0 Days — 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Healthcare Utilization [Time frame: 8 months]
Secondary outcome measures (6)
- Rates of pulmonary follow-up and use of telemedicine in follow-up [Time frame: 8 months]
- Completion of recommended evaluations and testing [Time frame: 8 months]
- Medication use [Time frame: 8 months]
- Home oxygen use [Time frame: 8 months]
- Feeding [Time frame: 8 months]
- Family satisfaction with care for respiratory symptoms around and after discharge [Time frame: 8 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT05285345 · IRB-P00039393