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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOWER oxygen saturation target group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Between discharge and 6 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80% | Total exposure to hypoxia - proportion of monitored time with SpO2 <80% | Between discharge and 6 months corrected age |
| Change in Weight Z-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara DeMauro, MD | The Childrens Hospital of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40167293 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LOWER Oxygen Saturation Target Group | Oxygen saturation target range 90--94%. 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. LOWER oxygen saturation target group: 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. |
| FG001 | HIGHER Oxygen Saturation Target Group | 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. HIGHER oxygen saturation target group: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LOWER Oxygen Saturation Target Group | 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. LOWER oxygen saturation target group: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Postmenstrual age (PMA) at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Infants with sufficient oximetry data were included in primary outcome analyses. | Posted | Median | Inter-Quartile Range | IH events per 8 hours of monitoring time | Between discharge and 6 months corrected age |
|
Data were collected between enrollment and 6 months corrected age
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LOWER Oxygen Saturation Target Group | Oxygen saturation target range 90--94%. 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. LOWER oxygen saturation target group: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara DeMauro | Children's Hospital of Philadelphia | 445-225-6400 | demauro@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2021 | Mar 15, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 6, 2021 | Apr 3, 2024 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
| HIGHER oxygen saturation target group | Other | 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. |
|
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.
| 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. | 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. | Between randomization and 6 months corrected age |
| Number of Participants With Re-hospitalization | Any re-hospitalization | Between discharge and 6 months corrected age |
| Number of Participants With Respiratory Medication Use | Number of patients with inhaled respiratory medication use | 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 | 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 | 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. | At 6 months corrected age |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| BG001 | HIGHER Oxygen Saturation Target Group | 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. HIGHER oxygen saturation target group: 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| post-menstrual age (PMA) in weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | HIGHER Oxygen Saturation Target Group | 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. HIGHER oxygen saturation target group: 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. |
|
|
| Secondary | Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80% | Total exposure to hypoxia - proportion of monitored time with SpO2 <80% | Analysis includes infant with sufficient oximetry data | Posted | Median | Inter-Quartile Range | proportion of monitored time | Between discharge and 6 months corrected age |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | delta Z-score | Between randomization and 6 months corrected age |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | delta Z-score | Between randomization and 6 months corrected age |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | delta Z-score | Between randomization and 6 months corrected age |
|
|
|
| Secondary | Number of Participants With Re-hospitalization | Any re-hospitalization | Posted | Count of Participants | Participants | Between discharge and 6 months corrected age |
|
|
|
| Secondary | Number of Participants With Respiratory Medication Use | Number of patients with inhaled respiratory medication use | Posted | Count of Participants | Participants | At 6 months corrected age |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | Between discharge and 6 months corrected age |
|
|
|
| Secondary | Feeding | Quality of infant oral feeding skills, parent reports that the child's feeding times are stressful or very stressful for themselves | Posted | Count of Participants | Participants | At 6 months corrected age |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 6 months corrected age |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | HIGHER Oxygen Saturation Target Group | 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. HIGHER oxygen saturation target group: 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. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |