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Completed

NCT Number: NCT03385330

BPD Saturation TARgeting

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Chronic Lung Disease Chronic Lung Disease of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

34 week–44 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOWER oxygen saturation target group

Other

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.

HIGHER oxygen saturation target group

Other

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.

Primary outcomes

  1. Intermittent Hypoxemia (IH) Events Per 8 Hours of Monitoring Time

    Time frame: Between discharge and 6 months corrected age

    Incidence of intermittent hypoxia (IH, defined as SpO2 <80% for >=30 seconds), reported as median number of events per 8 hours of monitoring time.

Secondary outcomes

  1. Duration of Hypoxia - Proportion of Monitored Time With Oxygen Saturation <80%

    Time frame: Between discharge and 6 months corrected age

    Total exposure to hypoxia - proportion of monitored time with SpO2 <80%

  2. Change in Weight Z-score

    Time frame: Between randomization and 6 months corrected age

    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.

  3. Change in Length Z-score

    Time frame: Between randomization and 6 months corrected age

    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.

  4. Change in Head Circumference Z-score

    Time frame: Between randomization and 6 months corrected age

    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.

  5. Number of Participants With Re-hospitalization

    Time frame: Between discharge and 6 months corrected age

    Any re-hospitalization

  6. Number of Participants With Respiratory Medication Use

    Time frame: At 6 months corrected age

    Number of patients with inhaled respiratory medication use

  7. Number of Participants With Visits to Emergency Room or Urgent Care for Respiratory Reasons

    Time frame: Between discharge and 6 months corrected age

    Any visits to ER or urgent care for respiratory health-related problems

  8. Feeding

    Time frame: At 6 months corrected age

    Quality of infant oral feeding skills, parent reports that the child's feeding times are stressful or very stressful for themselves

  9. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

The Bronchopulmonary Dysplasia Saturation TARgeting (BPD STAR) Pilot Trial

Acronym: BPD STAR

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2017
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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