What side effects are associated with this type of intervention?

Common treatments for hypoxemic respiratory failure include oxygen therapy, mechanical ventilation, and prone positioning. Oxygen therapy can lead to oxygen toxicity, resulting in lung damage and worsening respiratory failure if not carefully monitored. Mechanical ventilation, while life-saving, carries risks such as ventilator-associated pneumonia, barotrauma, and volutrauma. Prone positioning, used to improve oxygenation, can cause pressure sores, facial edema, and dislodgement of medical devices. These treatments require careful management to balance benefits and potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for hypoxemic respiratory failure, primarily focusing on oxygen therapy and mechanical ventilation strategies. Supplemental oxygen is a cornerstone treatment, often delivered through nasal cannulas, masks, or high-flow systems to maintain adequate oxygen saturation levels. Mechanical ventilation, including non-invasive methods like CPAP and BiPAP, is also commonly used. Additionally, inhaled nitric oxide has been approved for specific cases, particularly in neonates with hypoxic respiratory failure associated with pulmonary hypertension. These treatments aim to improve oxygenation and reduce the work of breathing in patients with severe respiratory distress.

What other types of research exist?

Promising novel alternatives to traditional oxygen saturation goals for hypoxemic respiratory failure patients include the use of lung recruitment maneuvers and titrated positive end-expiratory pressure (PEEP) strategies, as well as the implementation of diaphragm pacing for patients with respiratory muscle dysfunction. Additionally, emerging pharmacological treatments targeting specific pathways involved in respiratory failure, such as hypoxia-inducible factors, are also being explored.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at enrollment

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%

0 / 7Eligibility criteria met

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.