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NCT Number: NCT05285345

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.

Recruiting

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Key information

Age range

0 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Jonathan Levin, MD

CONTACT

[email protected]

617-335-1900

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Healthcare Utilization

    Time frame: 8 months

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

Secondary outcomes

  1. Rates of pulmonary follow-up and use of telemedicine in follow-up

    Time frame: 8 months

    Review of medical record

  2. Completion of recommended evaluations and testing

    Time frame: 8 months

    Review of medical record

  3. Medication use

    Time frame: 8 months

    Review of medical record

  4. Home oxygen use

    Time frame: 8 months

    Review of medical record

  5. Feeding

    Time frame: 8 months

    Review of medical record

  6. Family satisfaction with care for respiratory symptoms around and after discharge

    Time frame: 8 months

    Assessed by surveys

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Levin, MD

CONTACT

[email protected]

617-355-1900

Vanessa J Young

CONTACT

[email protected]

617-355-8330

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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