BPD Saturation TARgeting

Overview

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.

Full Title of Study: “The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2023

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Intermittent hypoxemia (IH)
    • Time Frame: Between discharge and 6 months corrected age
    • Incidence of intermittent hypoxia

Secondary Measures

  • Duration of hypoxia
    • Time Frame: Between discharge and 6 months corrected age
    • Total exposure to hypoxia(cm)
  • Weight change
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Growth in kilograms
  • Length change
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Growth in centimeters
  • Head circumference change
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Growth in centimeters
  • Weight-for-length change
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Change in weight-for-length
  • Re-hospitalization
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Rates of re-hospitalizations
  • Respiratory medication use
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Incidence of respiratory medication use
  • Visits to emergency room or physician
    • Time Frame: Between 40 weeks PMA and 6 months corrected age
    • Rates of visits to ER or physician for respiratory health-related problems
  • Quality of life
    • Time Frame: At 3 months and at 6 months corrected age
    • 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).
  • Feeding
    • Time Frame: At 3 months and at 6 months corrected age
    • Quality of infant oral feeding skills, using questions adapted from the Millennium Baby Study.
  • Development
    • Time Frame: At 6 months corrected age
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 34 Weeks

Maximum Age: 44 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Philadelphia
  • Collaborator
    • Thrasher Research Fund
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sara B. DeMauro, MD MSCE, Assistant Professor of Pediatrics – Children’s Hospital of Philadelphia
  • Overall Official(s)
    • Sara DeMauro, MD, Principal Investigator, The Childrens Hospital of Pennsylvania

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.