Oxygen Saturation Target for Newborn Pulmonary Hypertension
(POST-IT Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if keeping oxygen levels higher (95-99%) is better than slightly lower (91-95%) for newborns with lung problems. It aims to find the best oxygen range to help them breathe better and reduce lung pressure.

Research Team

Eligibility Criteria

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.

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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.

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Treatment Details

Interventions

95% - 99% SpO2 target ()

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention armExperimental Treatment1 Intervention

target preductal SpO2 - 95 to 99%

Group II: Standard armActive Control1 Intervention

target preductal SpO2 - 91 to 95%