An interventional study of LOWER oxygen saturation target group and HIGHER oxygen saturation target group in Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity and Chronic Lung Disease, sponsored by Children's Hospital of Philadelphia. Completed at 3 sites in United States. Open to participants aged 34 Weeks to 44 Weeks. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Other: LOWER 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.
Other: HIGHER 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.
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.
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.
Time frame: Between discharge and 6 months corrected age
Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%
Total exposure to hypoxia - proportion of monitored time with SpO2 \<80%
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between randomization and 6 months corrected age
Number of Participants With Re-hospitalization
Any re-hospitalization
Time frame: Between discharge and 6 months corrected age
Number of Participants With Respiratory Medication Use
Number of patients with inhaled respiratory medication use
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At 6 months corrected age
| Milestone | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Started | 28 | 22 |
| Completed | 23 | 19 |
| Not completed | 5 | 3 |
Incidence of intermittent hypoxia (IH, defined as SpO2 \<80% for \>=30 seconds), reported as median number of events per 8 hours of monitoring time.
| IH events per 8 hours of monitoring time | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time | 2.2 (1.0 to 4.2) | 1.2 (0.3 to 3.1) |
Total exposure to hypoxia - proportion of monitored time with SpO2 \<80%
| proportion of monitored time | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80% | 0.005 (0.001 to 0.016) | 0.004 (0.001 to 0.013) |
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.
| delta Z-score | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Change in Weight Z-score | 0.6 ± 1.4 | 0.5 ± 1.2 |
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.
| delta Z-score | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Change in Length Z-score | 1.7 ± 1.3 | 1.2 ± 1.4 |
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.
| delta Z-score | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Change in Head Circumference Z-score | 0.5 ± 1.3 | 0.4 ± 1.7 |
Any re-hospitalization
| Participants | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Number of Participants With Re-hospitalization | 9 | 6 |
Number of patients with inhaled respiratory medication use
| Participants | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Number of Participants With Respiratory Medication Use | 6 | 6 |
Any visits to ER or urgent care for respiratory health-related problems
| Participants | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons | 5 | 2 |
Quality of infant oral feeding skills, parent reports that the child's feeding times are stressful or very stressful for themselves
| Participants | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Feeding | 1 | 0 |
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.
| Participants | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group |
|---|---|---|
| Development | 8 | 3 |
Collected over Data were collected between enrollment and 6 months corrected age. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LOWER Oxygen Saturation Target Group | 0/28 (0%) | 0/28 (0%) | 0/28 (0%) |
| HIGHER Oxygen Saturation Target Group | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(post-menstrual age (PMA) in weeks) | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group | Total |
|---|---|---|---|
| Mean | 39.9 ± 2.3 | 40.5 ± 2.2 | 40.2 ± 2.3 |
| Sex: Female, Male(Participants) | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group | Total |
|---|---|---|---|
| Female | 14 | 9 | 23 |
| Male | 14 | 13 | 27 |
| Ethnicity (NIH/OMB)(Participants) | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 25 | 20 | 45 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LOWER Oxygen Saturation Target Group | HIGHER Oxygen Saturation Target Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 19 | 15 | 34 |
| White | 7 | 5 | 12 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Children's Hospital of Philadelphia