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

N/A
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postnatal age ≤ 28 days
Corrected gestational age (postmenstrual age) > 34 6/7 weeks
Must not have
A condition or congenital anomaly known to be lethal (high likelihood of death during infancy) - e.g., trisomy 18 or trisomy 13
Severe HRF with OI > 35 or SpO2 < 75% on FiO2 = 1.0 on mechanical ventilation for > 60 minutes in spite of correction of reversible factors such as pneumothorax
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3-7
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, monitoring oxygen saturation can affect breathing treatments and may lead to adjustments in respiratory support which could impact the baby's comfort and stability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby is 28 days old or younger.
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My baby is more than 34 weeks and 6 days old, counting from conception.
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I am on a breathing machine or need high oxygen support.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is often fatal in infancy, like trisomy 18 or 13.
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I have severe respiratory failure and have been on a ventilator for over an hour despite treatments.
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My weight is less than 2000 grams at enrollment.
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I have a heart condition, but it's not ASD/PFO, PDA, or VSD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hypoxemic Respiratory Failure and Pulmonary Hypertension (HRF/PH) score
Secondary study objectives
Intracluster correlation coefficients of the HRF/PH score
Preliminary estimates of intervention effects on outcomes (length of stay, duration of mechanical ventilation, and ECMO)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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%

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for hypoxemic respiratory failure include supplemental oxygen therapy, mechanical ventilation, and extracorporeal membrane oxygenation (ECMO). Supplemental oxygen therapy increases the amount of oxygen in the blood, improving tissue oxygenation. Mechanical ventilation supports or replaces spontaneous breathing, ensuring adequate oxygen delivery and carbon dioxide removal. ECMO provides cardiac and respiratory support by oxygenating blood outside the body, allowing the lungs to rest and heal. These treatments are crucial for hypoxemic respiratory failure patients as they directly address the critical issue of low blood oxygen levels, which can prevent organ damage and improve survival outcomes.
Pathophysiology of failure to wean from mechanical ventilation.[Ventilatory strategy for ARDS].Permissive hypercapnia: role in protective lung ventilatory strategies.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
935 Previous Clinical Trials
4,719,476 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,798 Previous Clinical Trials
8,141,495 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
354 Previous Clinical Trials
409,227 Total Patients Enrolled

Media Library

95% - 99% SpO2 target Clinical Trial Eligibility Overview. Trial Name: NCT04938167 — N/A
Hypoxemic Respiratory Failure Research Study Groups: Standard arm, Intervention arm
Hypoxemic Respiratory Failure Clinical Trial 2023: 95% - 99% SpO2 target Highlights & Side Effects. Trial Name: NCT04938167 — N/A
95% - 99% SpO2 target 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938167 — N/A
~1 spots leftby Dec 2024