Bronchopulmonary DysplasiaNCT05285345
Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
An observational study of Bronchopulmonary Dysplasia, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 1 year
- Conditions the study is for
- Bronchopulmonary Dysplasia
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 year
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Discharge to a location other than home.
- Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Jonathan Levin, MD, 617-335-1900, jonathan.levin@childrens.harvard.edu
About this study
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.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia, NICU Discharge
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Utilization
Review of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.
Measured: 8 months
Secondary outcomes (6)
Rates of pulmonary follow-up and use of telemedicine in follow-up
Review of medical record
Measured: 8 months
Completion of recommended evaluations and testing
Review of medical record
Measured: 8 months
Medication use
Review of medical record
Measured: 8 months
Home oxygen use
Review of medical record
Measured: 8 months
Feeding
Review of medical record
Measured: 8 months
Family satisfaction with care for respiratory symptoms around and after discharge
Assessed by surveys
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start27 Sep 2023
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Jonathan Levin, Boston Children's Hospital
- Investigators
- Jonathan Levin, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285345
- Sponsor's protocol ID
- IRB-P00039393
- Status last verified
- May 2026
- First submitted
- 9 Mar 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
- ClinicalTrials.gov ID
- NCT05285345
- Acronym / sponsor ID
- IRB-P00039393
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia, NICU Discharge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Discharge to a location other than home.
- Infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healthcare Utilization
Time frame: 8 months
Review of emergency encounters, urgent care visits, and hospital readmissions in the first 6 months after NICU discharge.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Levin, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Levin, MD (617-355-1900, jonathan.levin@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Utilization (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.