BPD Saturation TARgeting

Children's Hospital of Philadelphia50 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Chronic Lung Disease

Interventions

LOWER oxygen saturation target groupOTHER

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 groupOTHER

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.

Eligibility

Sex: ALLMin age: 34 WeeksMax age: 44 Weeks

Medical Language ↔ Plain English

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

Locations (3)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Between discharge and 6 months corrected age

Secondary Outcomes

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

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Between randomization and 6 months corrected age

Number of Participants With Re-hospitalization

Data from ClinicalTrials.gov

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