Oxygen Saturation Targeting for Bronchopulmonary Dysplasia

(PHOX Trial)

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

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

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+