Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
- Conditions
- Bronchopulmonary DysplasiaPulmonary Hypertension
- 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
- 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 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%
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%
Trial Locations
- Locations (2)
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
The University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United StatesColm TraversContact205-934-4011cptravers@uabmc.edu