Bronchopulmonary DysplasiaBPD STARNCT03385330
BPD Saturation TARgeting
A study testing LOWER oxygen saturation target group and HIGHER oxygen saturation target group in people with Bronchopulmonary Dysplasia and Chronic Lung Disease of Prematurity, run by Children's Hospital of Philadelphia at 3 sites in United States.
Trial summary
Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Read more about this study
- Who is it for?
- Ages 34 to 44 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease
- What is being tested?
- LOWER oxygen saturation target group and HIGHER oxygen saturation target group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2018to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-term males or females infants born at <30 0/7 weeks gestation at birth
- Current age 34 0/7 to 43 6/7 weeks postmenstrual age
- Diagnosis of moderate or severe Bronchopulmonary Dysplasia based on the NIH consensus definition
- Infant has never been discharged to home from the hospital
Who cannot join
- Congenital anomaly or oncologic process likely to affect growth or respiratory status
- Hemoglobinopathy or other blood disorder likely to affect oxygen saturations
- Contraindication to nasal cannula use (for example, severe nasal septal breakdown).
- Pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment.
- Tracheostomy
- Intubated during entire eligibility period
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.
Read the detailed description
Bronchopulmonary Dysplasia is diagnosed only in babies who are born prematurely, and affects about half of extremely preterm infants. The incidence of BPD has increased over time. It is most commonly defined as oxygen dependence at 36 weeks postmenstrual age (PMA).
Infants with BPD face more than doubled odds of death after 36 weeks PMA or disability at 5 years compared to preterm infants without BPD. BPD is associated with abnormal lung function throughout childhood and significantly increases health care costs. Cognitive and respiratory outcomes are closely linked throughout the life course; thus, optimal long--term management of BPD during infancy may ultimately improve cognitive outcomes of this high--risk population.
Supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited evidence about the safety or efficacy of using supplemental oxygen to target higher versus lower oxygen saturations in infants with established BPD.
Infants between the ages of 34-44 weeks post-menstrual age with moderate or severe BPD will be randomly assigned to higher or lower oxygen saturation target ranges. The study intervention will begin in the hospital and will continue at home until 6 months corrected age. When infants are discharged with supplemental oxygen, this will be titrated according to a study algorithm in order to ensure that the target saturations are maintained throughout the study period.
- Being tested
- LOWER oxygen saturation target group, HIGHER oxygen saturation target group
- Keywords
- BPD, Prematurity, Supplemental Oxygen, Oximetry, Infants
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOWER oxygen saturation target groupOther
We will randomize infants with moderate or severe BPD to lower SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
HIGHER oxygen saturation target groupOther
We will randomize infants with moderate or severe BPD to higher SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
| Study group | Role | What they receive |
|---|---|---|
| LOWER oxygen saturation target group | Active comparator | Oxygen saturation (SpO2) target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months corrected age (CA). Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm. Receives: Other: LOWER oxygen saturation target group |
| HIGHER oxygen saturation target group | Active comparator | Oxygen saturation target range greater than or equal to 96%.The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm. Receives: Other: HIGHER oxygen saturation target group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time
Incidence of intermittent hypoxia (IH, defined as SpO2 <80% for >=30 seconds), reported as median number of events per 8 hours of monitoring time.
Measured: Between discharge and 6 months corrected age
Secondary outcomes (9)
Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%
Total exposure to hypoxia - proportion of monitored time with SpO2 <80%
Measured: Between discharge and 6 months corrected age
Change in Weight Z-score
Change in weight Z-score. A Z-score of 0 represents average weight. Positive change in Z score indicates increasing weight relative to the population average weight. Negative change in Z score indicates decreasing weight relative to the population average weight.
Measured: Between randomization and 6 months corrected age
Change in Length Z-score
Change in length Z-score. A Z-score of 0 represents average length. Positive change in Z score indicates increasing length relative to the population average length. Negative change in Z score indicates decreasing length relative to the population average length.
Measured: Between randomization and 6 months corrected age
Change in Head Circumference Z-score
Change in head circumference (HC) Z-score. A Z-score of 0 represents average HC. Positive change in Z score indicates increasing HC relative to the population average HC. Negative change in Z score indicates decreasing HC relative to the population average HC.
Measured: Between randomization and 6 months corrected age
Number of Participants With Re-hospitalization
Any re-hospitalization
Measured: Between discharge and 6 months corrected age
Number of Participants With Respiratory Medication Use
Number of patients with inhaled respiratory medication use
Measured: At 6 months corrected age
Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons
Any visits to ER or urgent care for respiratory health-related problems
Measured: Between discharge and 6 months corrected age
Feeding
Quality of infant oral feeding skills, parent reports that the child's feeding times are stressful or very stressful for themselves
Measured: At 6 months corrected age
Development
Bayley Scales of Infant Development screening test, which is a standardized assessment of cognitive, motor, and language development in infancy and early childhood. Outcome will be reported as number of children considered "at risk" in any domain.
Measured: At 6 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start1 Jun 2018
- Primary completion1 Feb 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Principal investigator, Sara B. DeMauro, MD MSCE, Children's Hospital of Philadelphia
- Investigators
- Sara DeMauro, MD, Principal investigator, The Childrens Hospital of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385330
- Sponsor's protocol ID
- 17-014522
- Acronym
- BPD STAR
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2017
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
DeMauro SB, Jensen EA, Passarella M, Gambacorta MC, Dhawan M, Weimer J, Jang S, Panitch H, Kirpalani H. Oxygen Saturation Targeting for Infants with Bronchopulmonary Dysplasia: A Pilot Randomized Trial. Ann Am Thorac Soc. 2025 Apr;22(4):560-569. doi: 10.1513/AnnalsATS.202404-443OC.
PubMed 40167293
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
- ClinicalTrials.gov ID
- NCT03385330
- Acronym / sponsor ID
- BPD STAR / 17-014522
- Keywords
- BPD, Prematurity, Supplemental Oxygen, Oximetry, Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 28 Dec 2017 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchopulmonary dysplasia (BPD), or chronic lung disease of prematurity, affects nearly half of extremely preterm infants.This study evaluates the use of supplemental oxygen to manage infants with established BPD. Participants will be randomly placed in either a higher oxygen saturation group or a lower oxygen saturation target group.
Detailed description
Bronchopulmonary Dysplasia is diagnosed only in babies who are born prematurely, and affects about half of extremely preterm infants. The incidence of BPD has increased over time. It is most commonly defined as oxygen dependence at 36 weeks postmenstrual age (PMA).
Infants with BPD face more than doubled odds of death after 36 weeks PMA or disability at 5 years compared to preterm infants without BPD. BPD is associated with abnormal lung function throughout childhood and significantly increases health care costs. Cognitive and respiratory outcomes are closely linked throughout the life course; thus, optimal long--term management of BPD during infancy may ultimately improve cognitive outcomes of this high--risk population.
Supplemental oxygen is a lifesaving therapy for premature infants; yet, there is limited evidence about the safety or efficacy of using supplemental oxygen to target higher versus lower oxygen saturations in infants with established BPD.
Infants between the ages of 34-44 weeks post-menstrual age with moderate or severe BPD will be randomly assigned to higher or lower oxygen saturation target ranges. The study intervention will begin in the hospital and will continue at home until 6 months corrected age. When infants are discharged with supplemental oxygen, this will be titrated according to a study algorithm in order to ensure that the target saturations are maintained throughout the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOWER oxygen saturation target group | Active comparator | Other: LOWER oxygen saturation target groupOxygen saturation (SpO2) target range 90--94%. The study intervention will begin in the hospital and will continue at home until 6 months corrected age (CA). Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm. |
| HIGHER oxygen saturation target group | Active comparator | Other: HIGHER oxygen saturation target groupOxygen saturation target range greater than or equal to 96%.The study intervention will begin in the hospital and will continue at home until 6 months CA. Overnight continuous oximetry will be transmitted wirelessly to the study team. In hospital, inspired oxygen will be adjusted as needed to maintain target SpO2. Monitoring will continue after discharge, and oxygen flow will be titrated monthly according to a standardized algorithm. |
Who may qualify
- Ages
- 34 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pre-term males or females infants born at <30 0/7 weeks gestation at birth
- Current age 34 0/7 to 43 6/7 weeks postmenstrual age
- Diagnosis of moderate or severe Bronchopulmonary Dysplasia based on the NIH consensus definition
- Infant has never been discharged to home from the hospital
Key exclusion criteria (6 listed)
- Congenital anomaly or oncologic process likely to affect growth or respiratory status
- Hemoglobinopathy or other blood disorder likely to affect oxygen saturations
- Contraindication to nasal cannula use (for example, severe nasal septal breakdown).
- Pulmonary hypertension requiring pharmacotherapy at the time of screening/enrollment.
- Tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOWER oxygen saturation target groupWe will randomize infants with moderate or severe BPD to lower SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges. | Other | LOWER oxygen saturation target group |
| HIGHER oxygen saturation target groupWe will randomize infants with moderate or severe BPD to higher SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges. | Other | HIGHER oxygen saturation target group |
Primary outcome
Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time
Time frame: Between discharge and 6 months corrected age
Incidence of intermittent hypoxia (IH, defined as SpO2 <80% for >=30 seconds), reported as median number of events per 8 hours of monitoring time.
9 secondary outcomes
Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%
Time frame: Between discharge and 6 months corrected age
Change in Weight Z-score
Time frame: Between randomization and 6 months corrected age
Change in Length Z-score
Time frame: Between randomization and 6 months corrected age
Change in Head Circumference Z-score
Time frame: Between randomization and 6 months corrected age
Number of Participants With Re-hospitalization
Time frame: Between discharge and 6 months corrected age
Number of Participants With Respiratory Medication Use
Time frame: At 6 months corrected age
Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons
Time frame: Between discharge and 6 months corrected age
Feeding
Time frame: At 6 months corrected age
Development
Time frame: At 6 months corrected age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40167293DeMauro SB, Jensen EA, Passarella M, Gambacorta MC, Dhawan M, Weimer J, Jang S, Panitch H, Kirpalani H. Oxygen Saturation Targeting for Infants with Bronchopulmonary Dysplasia: A Pilot Randomized Trial. Ann Am Thorac Soc. 2025 Apr;22(4):560-569. doi: 10.1513/AnnalsATS.202404-443OC.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sara DeMauro, MD principal investigator
The Childrens Hospital of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOWER oxygen saturation target group and HIGHER oxygen saturation target group in people with Bronchopulmonary Dysplasia and Chronic Lung Disease of Prematurity, run by Children's Hospital of Philadelphia at 3 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time (time frame: Between discharge and 6 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03385330, which also lists 1 linked publication.
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 30 Apr 2024.