BPD Saturation TARgeting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial

Conditions
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Bronchopulmonary Dysplasia, Chronic Lung Disease of Prematurity, Chronic Lung Disease

Intervention / Treatment
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* Other: LOWER oxygen saturation target group
* Other: HIGHER oxygen saturation target group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 34 Weeks
Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LOWER oxygen saturation target group<br>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. | Other: LOWER oxygen saturation target group<br>* 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.<br>|
| Active Comparator: HIGHER oxygen saturation target group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermittent hypoxemia (IH) | Incidence of intermittent hypoxia | Between discharge and 6 months corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hypoxia | Total exposure to hypoxia(cm) | Between discharge and 6 months corrected age | 
| Weight change | Growth in kilograms | Between 40 weeks PMA and 6 months corrected age | 
| Length change | Growth in centimeters | Between 40 weeks PMA and 6 months corrected age | 
| Head circumference change | Growth in centimeters | Between 40 weeks PMA and 6 months corrected age | 
| Weight-for-length change | Change in weight-for-length | Between 40 weeks PMA and 6 months corrected age | 
| Re-hospitalization | Rates of re-hospitalizations | Between 40 weeks PMA and 6 months corrected age | 
| Respiratory medication use | Incidence of respiratory medication use | Between 40 weeks PMA and 6 months corrected age | 
| Visits to emergency room or physician | Rates of visits to ER or physician for respiratory health-related problems | Between 40 weeks PMA and 6 months corrected age | 
| Quality of life | Quality of life, as measured by the Infant Toddler Quality of life Questionnaire (IT-QOL). Scores are reported on a scale from 0 (worst health) to 100 (best health). | At 3 months and at 6 months corrected age | 
| Feeding | Quality of infant oral feeding skills, using questions adapted from the Millennium Baby Study. | At 3 months and 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPD, Prematurity, Supplemental Oxygen, Oximetry, Infants