- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03385330
BPD Saturation TARgeting (BPD STAR)
The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intermittent hypoxemia (IH)
Time Frame: Between discharge and 6 months corrected age
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Incidence of intermittent hypoxia
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Between discharge and 6 months corrected age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of hypoxia
Time Frame: Between discharge and 6 months corrected age
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Total exposure to hypoxia(cm)
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Between discharge and 6 months corrected age
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Weight change
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Growth in kilograms
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Between 40 weeks PMA and 6 months corrected age
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Length change
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Growth in centimeters
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Between 40 weeks PMA and 6 months corrected age
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Head circumference change
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Growth in centimeters
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Between 40 weeks PMA and 6 months corrected age
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Weight-for-length change
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Change in weight-for-length
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Between 40 weeks PMA and 6 months corrected age
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Re-hospitalization
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Rates of re-hospitalizations
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Between 40 weeks PMA and 6 months corrected age
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Respiratory medication use
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Incidence of respiratory medication use
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Between 40 weeks PMA and 6 months corrected age
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Visits to emergency room or physician
Time Frame: Between 40 weeks PMA and 6 months corrected age
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Rates of visits to ER or physician for respiratory health-related problems
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Between 40 weeks PMA and 6 months corrected age
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Quality of life
Time Frame: At 3 months and at 6 months corrected age
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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).
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At 3 months and at 6 months corrected age
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Feeding
Time Frame: At 3 months and at 6 months corrected age
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Quality of infant oral feeding skills, using questions adapted from the Millennium Baby Study.
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At 3 months and at 6 months corrected age
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Development
Time Frame: At 6 months corrected age
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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
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sara DeMauro, MD, The Childrens Hospital of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Infant, Newborn, Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Lung Injury
- Infant, Premature, Diseases
- Ventilator-Induced Lung Injury
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Lung Diseases
- Premature Birth
- Bronchopulmonary Dysplasia
Other Study ID Numbers
- 17-014522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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