BPD Saturation TARgeting (BPD STAR)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Lung Disease; Bronchopulmonary Dysplasia; Chronic Lung Disease of Prematurity
• Intervention / Treatment: Other: LOWER oxygen saturation target group; Other: HIGHER 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 10 months (Child)
• Accepts Healthy Volunteers: No

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Thrasher Research Fund
• Investigators: Principal Investigator: Sara DeMauro, MD, The Childrens Hospital of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Infants; Prematurity; BPD; Oximetry; Supplemental Oxygen
• 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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes