Oxygen Saturation Target for Newborn Pulmonary Hypertension

(POST-IT Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Gestation < 32 weeks, Weight < 2000 g, Severe HRF, Lethal anomaly, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal oxygen levels for newborns with pulmonary hypertension, a condition that hinders adequate oxygen intake in their lungs. Babies in the trial will be assigned to one of two groups, each with different oxygen targets, to determine which is more effective. One group will aim for a 95% - 99% SpO2 target (oxygen saturation level). Suitable newborns should be older than 34 weeks from conception, less than 28 days old, and currently receiving respiratory support, such as a ventilator or CPAP. Participants will undergo medical record reviews and targeted heart and lung assessments. As an unphased trial, this study seeks to gather valuable insights that could enhance care for newborns with pulmonary hypertension.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these oxygen saturation targets are safe for newborns with pulmonary hypertension?

A previous study with lambs found that maintaining oxygen levels between 95% and 99% resulted in the lowest lung pressure. This suggests that higher oxygen levels might be safe and beneficial for newborns with high blood pressure in the lungs. Another study recommended slightly higher oxygen levels for premature babies to prevent low oxygen episodes. While these findings are promising, research is ongoing, and individual results can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new oxygen saturation target for treating newborn pulmonary hypertension. Unlike the standard approach, which targets an SpO2 range of 91% to 95%, this trial investigates the effects of maintaining a higher oxygen saturation level of 95% to 99%. The hope is that by optimizing oxygen levels, we can improve outcomes for newborns with this condition, potentially reducing complications and enhancing recovery. This trial could redefine best practices in managing newborn pulmonary hypertension by providing clearer guidelines on oxygen saturation targets.

What evidence suggests that this trial's oxygen saturation targets could be effective for newborn pulmonary hypertension?

This trial will compare two oxygen saturation targets for newborns with pulmonary hypertension. Research has shown that increasing oxygen levels to 95-99% in these newborns might reduce the severity of their condition. Participants in the intervention arm will have their oxygen levels targeted at 95-99%, potentially easing blood flow through the lungs, improving breathing, and reducing heart strain. The standard arm will maintain oxygen levels between 91-95%, following usual practice. Some studies suggest that raising oxygen levels to 95-99% could benefit some newborns, but there is debate due to the potential for higher oxygen levels to cause lung problems. This research aims to explore these possible benefits and risks further. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for newborns up to 28 days old with pulmonary hypertension or related conditions, needing respiratory support and oxygen. They must weigh over 2000g and be born after at least 32 weeks of gestation. Babies with certain heart defects or lethal conditions like trisomy 18 or trisomy 13 cannot participate.

Inclusion Criteria

My baby is 28 days old or younger.

My baby is more than 34 weeks and 6 days old, counting from conception.

My infant has CDH, Down syndrome, HIE, PDA, PFO/ASD, or VSD less than 2 mm.

Exclusion Criteria

My condition is often fatal in infancy, like trisomy 18 or 13.

I was born before reaching 32 weeks of pregnancy.

I have severe respiratory failure and have been on a ventilator for over an hour despite treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomly assigned to one of two oxygen saturation goals and monitored for changes in pulmonary hypertension and respiratory failure

7 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 95% - 99% SpO2 target

Trial Overview The study tests two different goals for blood oxygen levels (95%-99% SpO2) in newborns with pulmonary issues. Participants will be randomly assigned a target range, have their medical records reviewed, and undergo targeted echocardiograms to assess the effects.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

target preductal SpO2 - 95 to 99%

Group II: Standard arm Active Control 1 Intervention

target preductal SpO2 - 91 to 95%

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10857735/

Oxygen Targets in Neonatal Pulmonary Hypertension Preterm infants with BPD-PH, slightly higher SpO2 targets between 92–95% is recommended to prevent episodes of hypoxemia.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378378224002032

Oxygen saturation targets in neonatal care A target SpO2 of 90–95 % is generally reasonable for term infants with respiratory disease or pulmonary hypertension, with few exceptions such as severe ...

3. neonatalresearch.org neonatalresearch.org/2024/10/04/what-should-saturation-targets-be-in-established-chronic-lung-disease-with-pulmonary-hypertension/

What should saturation targets be in established chronic ... The consensus seems to be that 92-95% is probably best. Higher targets have no known benefits, and may increase pulmonary toxicity and adverse outcomes.

4. mdpi.com mdpi.com/2227-9067/9/3/396

Factors to Consider to Study Preductal Oxygen Saturation ... Our primary hypothesis is that in neonates with PH and HRF, targeting preductal SpO2 of 95–99% (intervention) will result in lower PVR and ...

5. studypages.com studypages.com/s/testing-levels-of-oxygen-in-newborns-with-pulmonary-hypertension-800422/

Testing Levels of Oxygen in Newborns with Pulmonary ... Currently the most common oxygen goal used is 91-95%. Based on our prior research, targeting a higher level (95-99%) may decrease the pulmonary hypertension and ...

6. mdpi.com mdpi.com/2077-0383/14/11/3975

Oxygen Saturation Targeting in the Neonatal Intensive ... A preclinical study using lambs demonstrated that maintaining preductal O2 saturation targets between 95% and 99% resulted in the lowest pulmonary vascular ...

7. pdfs.semanticscholar.org pdfs.semanticscholar.org/ff02/396bd3be964446884a036b1ac57825c39825.pdf

Factors to Consider to Study Preductal Oxygen Saturation ... Our primary hypothesis is that in neonates with PH and HRF, targeting preductal SpO2 of 95–99% (intervention) will result in lower pulmonary ...

8. thieme-connect.com thieme-connect.com/products/ejournals/abstract/10.1055/s-0044-1780523

Variability in Practice and Implementation of Oxygen Target ... This study aimed to describe target oxygen saturation (SpO 2 ) ranges used for premature infants in United States' neonatal intensive care units (NICUs)

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

Achieved oxygen saturations and risk for bronchopulmonary ... In a model of term gestation lambs, pulmonary blood flow was assessed following asphyxia and randomisation to three SpO2 targets: 85–89%, 90–94% and 95–99%.