Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
- Conditions
- Bronchopulmonary DysplasiaPulmonary Hypertension
- Interventions
- Device: higher oxygen saturation target using Nellcor pulse oximetry sensorsDevice: lower oxygen saturation target using Nellcor pulse oximetry sensors
- Registration Number
- NCT06373289
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 39
- Between 22w 0/7d and 31w 6/7d gestation at birth
- Diagnosed with echocardiographic pulmonary hypertension (1) >20% flow of blood across the PDA from the pulmonary to arterial circulation, (2) end-systolic flattening of the interventricular septum (eccentricity index >1.3), or (3) right ventricular pressure estimates ≥ 35 mm Hg
- Receiving supplemental oxygen
- Have mature retinas
- Major congenital anomalies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Oxygen saturation target 95-98% higher oxygen saturation target using Nellcor pulse oximetry sensors At UAB 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 2 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets. Oxygen saturation target 92-95% lower oxygen saturation target using Nellcor pulse oximetry sensors At UAB 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 for a 2 week period after which they will crossover to the alternative oxygen saturation target with a 1 week washout period in between targets.
- Primary Outcome Measures
Name Time Method Intermittent hypoxemia event duration From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%.
- Secondary Outcome Measures
Name Time Method Brain natriuretic peptide From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first A polypeptide released from the cardiac ventricles indicative of right heart strain
Echocardiographic interventricular septal flattening From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first End-systolic flattening of the interventricular septum (eccentricity index \>1.3)
Echocardiographic tricuspid regurgitation From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first Right ventricular pressure estimates
Cumulative hypoxemia From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first Daily duration during which an infant's oxygen saturation is \<80%
Echocardiographic shunting through study completion, 3 weeks from date of randomization until 3 weeks have elapsed or date of discharge, whichever came first \>20% flow of blood across the PDA from the pulmonary to arterial circulation
Intermittent hypoxemia frequency From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first Number of daily events during which an infant's oxygen saturation decreases below 80%