Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: higher oxygen saturation target using Nellcor pulse oximetry sensors, lower oxygen saturation target using Nellcor pulse oximetry sensors.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia, Pulmonary Hypertension. Basic parameters: 1 months — 5 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Overview
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.
Interventions
- Device higher oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the higher oxygen saturation target. - Device lower oxygen saturation target using Nellcor pulse oximetry sensors
The intervention will be a cross over exposure to the lower oxygen saturation target.
Primary outcome measures
- Intermittent hypoxemia event duration [Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
Secondary outcome measures (6)
- Echocardiographic shunting [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 [Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
- Echocardiographic tricuspid regurgitation [Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
- Intermittent hypoxemia frequency [Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
- Cumulative hypoxemia [Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
- Brain natriuretic peptide [Time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Major congenital anomalies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- The University of Alabama at Birmingham — Birmingham
- Yale New Haven Hospital — New Haven
Identifiers
NCT: NCT06373289 · 000539476 · 1K23HD113837-01A1