An interventional study of higher oxygen saturation target using Nellcor pulse oximetry sensors and lower oxygen saturation target using Nellcor pulse oximetry sensors in Bronchopulmonary Dysplasia and Pulmonary Hypertension, sponsored by University of Alabama at Birmingham. Recruiting at 2 sites in United States. Open to participants aged 1 Month to 5 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
Around 50% of infants born extremely preterm develop a chronic lung disease known as bronchopulmonary dysplasia of which some infants will also develop pulmonary hypertension of which 50% of children will die before the age of 2. Physicians are currently limited in their ability to select the most appropriate oxygen targets that will improve outcomes in infants with this condition. This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease.
Infants born between 22.0 to 31.6 weeks' gestational age with bronchopulmonary dysplasia associated pulmonary hypertension, are receiving supplemental oxygen, and have mature retinas will be randomized to SpO2 targets of either (1) 92-95% (control) or (2) 95-98% (intervention).
Using a cross over design with a 1:1 parallel allocation of infants randomized using a stratified permuted block design. Following 1week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period. Bedside providers will follow pre-specified algorithms to maintain oxygen targets during the randomization period. Reports of oxygen saturation performance will also be provided to bedside providers through oxygen saturation histograms.
Exclusion Criteria:
At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 92-95% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed to a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.
Device: lower oxygen saturation target using Nellcor pulse oximetry sensors
At UAB and Yale oxygen saturation targeting is achieved using systematic oxygen saturation histogram monitoring every 3-4 hours by nurse, respiratory therapists, and physicians. Upon randomization to this arm, infants oxygen saturation alarm limits will be adjusted to 95-98% after which an FiO2 modification algorithm will be employed to maintain targets. Daily compliance reports will be generated to ensure oxygen saturation achievement corresponds with oxygen saturation targets. Infants will be exposed for a 1 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.
Device: higher oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the higher oxygen saturation target.
The intervention will be a cross over exposure to the lower oxygen saturation target.
Intermittent hypoxemia event duration
The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%.
Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Echocardiographic shunting
\>20% flow of blood across the PDA from the pulmonary to arterial circulation
Time frame: through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Echocardiographic interventricular septal flattening
End-systolic flattening of the interventricular septum (eccentricity index \>1.3)
Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Echocardiographic tricuspid regurgitation
Right ventricular pressure estimates
Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Intermittent hypoxemia frequency
Number of daily events during which an infant's oxygen saturation decreases below 80%
Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Cumulative hypoxemia
Daily duration during which an infant's oxygen saturation is \<80%
Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Brain natriuretic peptide
A polypeptide released from the cardiac ventricles indicative of right heart strain
Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Plan to share: No
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University of Alabama at Birmingham