Oxygen Saturation Targeting for Bronchopulmonary Dysplasia

(PHOX Trial)

Not yet recruiting at 1 trial location

Overseen By Samuel Gentle, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Major congenital anomalies

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different oxygen levels can aid infants born extremely early who develop bronchopulmonary dysplasia, a chronic lung disease. Many of these infants also experience pulmonary hypertension (high blood pressure in the lungs), which significantly impacts their survival. The study tests two oxygen saturation targets, 92-95% and 95-98%, to determine which improves the infants' health outcomes. Infants between 22 and 31 weeks gestation at birth, diagnosed with pulmonary hypertension, and receiving extra oxygen might be suitable for this trial. Nellcor pulse oximetry sensors will monitor the infants' oxygen levels. As an unphased trial, this study provides a unique opportunity to contribute to vital research that could enhance care for future infants with similar conditions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Nellcor pulse oximetry sensors are safe for infants?

Research has shown that Nellcor pulse oximetry sensors, used in this study, have been widely tested and safely used in many patients. These sensors monitor oxygen levels in the blood, which is crucial for babies with lung problems like bronchopulmonary dysplasia.

A review of nearly 300 studies highlights the benefits and safety of using Nellcor sensors across different patient groups. These studies suggest that the sensors are well-tolerated, with no major side effects reported. Thus, the sensors are generally considered safe for checking oxygen levels in babies and other patients.

Although this trial does not test a new drug or invasive treatment, it aims to determine the best oxygen levels to support babies' health. The sensors have a strong safety record, providing reassurance for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to manage oxygen levels in infants with bronchopulmonary dysplasia (BPD). Unlike typical treatments that may not have precise guidelines for oxygen saturation, this trial compares two specific oxygen saturation targets—92-95% and 95-98%—using advanced monitoring techniques. The goal is to find out which target range is safer and more effective for infants. By carefully adjusting oxygen levels and employing systematic monitoring, they aim to optimize infant care and potentially improve outcomes for those with BPD.

What evidence suggests that this trial's treatments could be effective for bronchopulmonary dysplasia?

Research has shown that Nellcor pulse oximetry sensors can help manage oxygen levels in babies with bronchopulmonary dysplasia (BPD). In this trial, infants will be randomized into two treatment arms, each with different oxygen saturation targets. One arm will target oxygen saturation levels of 92-95%, while the other will target 95-98%. Studies indicate that adjusting oxygen level targets can lead to better health outcomes for these babies. Babies with both BPD and high blood pressure in the lungs often have lower oxygen levels, so careful oxygen management is crucial. These sensors are designed to maintain oxygen levels within safe ranges, reducing risks associated with the condition. Extensive research supports the use of these sensors, proving them effective in managing oxygen levels in similar patient groups. ^{1 3 4 6 7}

Who Is on the Research Team?

Samuel Gentle

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for preterm infants on supplemental oxygen, born between 22 and almost 32 weeks of gestation, diagnosed with pulmonary hypertension via echocardiography, and who have a certain level of retinopathy or mature retinas. Infants are excluded if they don't meet these specific criteria.

Inclusion Criteria

My baby was born between 22 and 31 weeks of pregnancy.

Diagnosed with echocardiographic pulmonary hypertension defined as: (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

I am using supplemental oxygen.

Exclusion Criteria

Major congenital anomalies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants are randomized to different oxygen saturation targets with a crossover design, including a 1-week washout period between exposures

3 weeks

Daily monitoring by nurses, respiratory therapists, and physicians

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks or until discharge

What Are the Treatments Tested in This Trial?

Interventions

• Nellcor pulse oximetry sensors

Trial Overview The study tests two different oxygen saturation levels in preterm infants with bronchopulmonary dysplasia and pulmonary hypertension to see which improves outcomes. They're using Nellcor pulse oximetry sensors to monitor the effects of higher versus lower oxygen targets.

How Is the Trial Designed?

Group I: Oxygen saturation target 92-95% Active Control 1 Intervention

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.

Group II: Oxygen saturation target 95-98% Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10487283/

Information Based Similarity Analysis of Oxygen Saturation ... Bedside cardiorespiratory monitoring was carried out by Philips IntelliVue MP70 or MP50 monitors using Nellcor pulse oximetry sensors, an averaging time of 8 ...

2. adc.bmj.com adc.bmj.com/content/109/11/941

Achieved oxygen saturations and risk for bronchopulmonary ... In this prospective observational study, infants with BPD-PH achieved lower SpO2 distributions compared with infants with BPD alone. In evaluating related ...

3. withpower.com withpower.com/trial/oxygen-saturation-targeting-for-bronchopulmonary-dysplasia-5b68b

Oxygen Saturation Targeting for Bronchopulmonary ... ... Nellcor pulse oximetry sensors will have tolerable side effects & efficacy for patients with Bronchopulmonary Dysplasia, Pulmonary Hypertension ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/3763297/

Pulse oximetry advantages in infants with ... We studied 12 infants with a clinical and radiologic diagnosis of bronchopulmonary dysplasia who were oxygen dependent and older than 30 days.

5. medtronic.com medtronic.com/covidien/en-gb/products/pulse-oximetry/clinical.html

Nellcor™ Pulse Oximetry Clinical Evidence Bibliography Nellcor™ Pulse Oximetry Clinical Studies - Review nearly 300 studies that highlight the benefits of Nellcor™ pulse oximetry in a wide variety of patients.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06373289

Pulmonary Hypertension and Oxygen Saturation Targeting ... This clinical trial will determine whether using different amounts of oxygen improve outcomes in infants with this disease. Detailed Description. Infants born ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526054225000296

Towards standardized and clinically relevant definitions of ... Pulse oximetry (Philips IntelliVue MP70 or MP50, using Nellcor sensors), Averaging time: 8 s. Sample rate: 125 Hz, Bronchopulmonary dysplasia ...