Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Major congenital anomalies
Trial design
Design model
Crossover
Treatments tested in this trial
higher oxygen saturation target using Nellcor pulse oximetry sensors
DeviceThe intervention will be a cross over exposure to the higher oxygen saturation target.
lower oxygen saturation target using Nellcor pulse oximetry sensors
DeviceThe intervention will be a cross over exposure to the lower oxygen saturation target.
Treatment groups
39 Participants
are divided into 2 treatment groupsGroup A: Oxygen saturation target 92-95%Active comparator 1 intervention
Group B: Oxygen saturation target 95-98%Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 firstSecondary outcomes
1
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 first2
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 first3
Echocardiographic tricuspid regurgitation
Right ventricular pressure estimates
Time frame
From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first4
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 firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Yale University
Sponsor institution
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov