Bronchopulmonary DysplasiaPHOXNCT06373289
Pulmonary Hypertension and Oxygen Saturation Targeting in Preterm Infants
A study testing higher oxygen saturation target using Nellcor pulse oximetry sensors and lower oxygen saturation target using Nellcor pulse oximetry sensors in people with Bronchopulmonary Dysplasia and Pulmonary Hypertension, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia, Pulmonary Hypertension
- What is being tested?
- higher oxygen saturation target using Nellcor pulse oximetry sensors and lower oxygen saturation target using Nellcor pulse oximetry sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2026to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Major congenital anomalies
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colm Travers contact
United States2 sites, 2 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35294
Colm Travers, 205-934-4011, cptravers@uabmc.edu
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06510
Samuel Gentle, 205-541-2247, samuel.gentle@yale.edu
About this study
Official title: Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
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.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension
- Being tested
- higher oxygen saturation target using Nellcor pulse oximetry sensors, lower oxygen saturation target using Nellcor pulse oximetry sensors
- Medical subject headings
- Bronchopulmonary Dysplasia, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
higher oxygen saturation target using Nellcor pulse oximetry sensorsDevice
The intervention will be a cross over exposure to the higher oxygen saturation target.
lower oxygen saturation target using Nellcor pulse oximetry sensorsDevice
The intervention will be a cross over exposure to the lower oxygen saturation target.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen saturation target 92-95% | Active comparator | 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. Receives: Device: lower oxygen saturation target using Nellcor pulse oximetry sensors |
| Oxygen saturation target 95-98% | Active comparator | 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. Receives: Device: higher oxygen saturation target using Nellcor pulse oximetry sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intermittent hypoxemia event duration
The average duration of time (in seconds) an infant's oxygen saturation decrease below 80%.
Measured: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Secondary outcomes (6)
Echocardiographic shunting
>20% flow of blood across the PDA from the pulmonary to arterial circulation
Measured: 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)
Measured: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Echocardiographic tricuspid regurgitation
Right ventricular pressure estimates
Measured: 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%
Measured: 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%
Measured: 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
Measured: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start22 Sep 2026
- Primary completion6 Jul 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 1 week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Samuel Gentle, Yale University
- Investigators
- Samuel Gentle, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373289
- Sponsor's protocol ID
- 000539476
- Other IDs
- 1K23HD113837-01A1
- Acronym
- PHOX
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Oxygen Saturation Ranges in Infants With Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06373289
- Acronym / sponsor ID
- PHOX / 000539476
- Conditions
- Bronchopulmonary Dysplasia, Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 6 Jul 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, randomized cross-over pilot study with a 1:1 parallel allocation of infants to SpO2 targets of 92-95% (control) and 95-98% (intervention) using a stratified permuted block design. Following 1 week of exposure A, infants will cross over to exposure B for 1 week with a 1-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Oxygen saturation target 92-95% | Active comparator | Device: lower oxygen saturation target using Nellcor pulse oximetry sensorsAt 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. |
| Oxygen saturation target 95-98% | Active comparator | Device: higher oxygen saturation target using Nellcor pulse oximetry sensorsAt 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. |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Major congenital anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| higher oxygen saturation target using Nellcor pulse oximetry sensorsThe intervention will be a cross over exposure to the higher oxygen saturation target. | Device | Oxygen saturation target 95-98% |
| lower oxygen saturation target using Nellcor pulse oximetry sensorsThe intervention will be a cross over exposure to the lower oxygen saturation target. | Device | Oxygen saturation target 92-95% |
Primary outcome
Intermittent hypoxemia event duration
Time frame: 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%.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colm Travers contact
Samuel Gentle principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing higher oxygen saturation target using Nellcor pulse oximetry sensors and lower oxygen saturation target using Nellcor pulse oximetry sensors in people with Bronchopulmonary Dysplasia and Pulmonary Hypertension, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel Gentle, MD (205-541-2247, samjgentle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intermittent hypoxemia event duration (time frame: From date of randomization until 3 weeks have elapsed or date of discharge, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.