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 2026-10-06.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment
Among 147 studies in Bronchopulmonary Dysplasia with a site in United States — 30 open to participants now, 37 under way, 1 of them phase 3. Bronchopulmonary Dysplasia · United States.
Among the 147 studies in Bronchopulmonary Dysplasia with a site in United States, this one is the 69th largest by planned enrollment of the 117 interventional ones that give a count, is one of 12 that started in 2026, is one of 46 with no phase, reaches primary completion later than 35 of the 36 other live ones, and was the 129th registered.
362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.
Browse Bronchopulmonary Dysplasia studies →30 of the 147 studies in Bronchopulmonary Dysplasia with a site in United States are open now. Recruiting first, the newest first:
NICHD Neonatal Research Network · Sites in United States
Ages up to 31 wk
University of Alabama at Birmingham · Sites in United States
Ages 7 days–30 days
University of Alabama at Birmingham · Sites in United States
Ages 1 days–3 days
Augusta University · Sites in United States
Ages 25 wk–34 wk
Indiana University · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 58 Bronchopulmonary Dysplasia studies recruiting now, 7 (12%) set no upper age limit and 50 (86%) stop at 75 or younger; 56 take children under 18; 11 take healthy volunteers.
This study: 1 Month to 5 Months · all sexes · healthy volunteers too.
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147 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 36 · Phase 3 20 · Phase 4 7
First in 1991; this study’s year is marked. 12 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 39 is below the median of 66 across 244 interventional studies indexed under Bronchopulmonary Dysplasia.
Median enrollment 50 across the 117 interventional studies, 155 across the 30 observational. Of the 99 that completed or were terminated, 42 (42%) have results posted.
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11 of 147 have an industry lead sponsor. The 10 most frequent:
University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
University of Alabama at Birmingham has 9 studies filed under Bronchopulmonary Dysplasia — fewer than ten, so there is no comparison to draw.
20 of the studies in Bronchopulmonary Dysplasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT03797183University of Colorado, DenverGenesis Electrical Impedance Tomography (EIT): A Preliminary Study | 2026-11 |
| NCT04372953Murdoch Childrens Research InstitutePositive End-Expiratory Pressure (PEEP) Levels During Resuscitation of Preterm Infants at Birth (The POLAR Trial). | 2026-11-30 |
| NCT05568264Shirley Ryan AbilityLabEffects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit | 2026-12-31 |
| NCT07447739Khang NguyenCan Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively? | 2027-03 |
Among the 147 studies in Bronchopulmonary Dysplasia with a site in United States, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jul 2029, 33 months after the start.
Of 71 non-industry interventional studies with no phase under Bronchopulmonary Dysplasia, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 33 months is above that.
Counting every sponsor, half of 73 studies reached it within 37 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University of Alabama at Birmingham →