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Controlled Oxygen Levels for Congenital Heart Defects (T-NOX Trial)

Q: How many people have volunteered to take part in this research endeavor?

<p>Affirmative. The details hosted on clinicaltrials.gov indicate that this medical trial, first posted in January 18th 2021, is currently recruiting participants. 42 individuals need to be sourced from a single site for the purpose of the study.</p>

Q: Will the research team accept additional participants at this time?

<p>Indeed, the information posted on clinicaltrials.gov specifies that this medical investigation is still actively searching for participants. The research project was initially published on January 18th 2021 and was recently modified on June 22nd 2022; 42 individuals are being recruited from a single study site.</p>

N/A

Waitlist Available

Led By Nathaniel Sznycer-Taub, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest)

Transposition physiology (example: D-Transposition of the great arteries or Double outlet right ventricle with subpulmonary VSD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Awards & highlights

T-NOX Trial Summary

This trial is studying if different levels of oxygen exposure during and after surgery is safe for infants. There will be blood samples and ultrasounds taken. The trial has two groups- one that is the standard of care and the other is normoxia. They are testing to see if there is a difference in adverse events and in the measured partial pressure of oxygen values.

Who is the study for?

This trial is for infants under 30 days old with certain types of congenital heart disease causing low oxygen levels. They must need heart surgery involving cardiopulmonary bypass and have not had previous cardiac surgeries, ECMO support, or dialysis.Check my eligibility

What is being tested?

The study compares standard care ventilation to controlled re-oxygenation (normoxia) during/after heart surgery in infants. It aims to see if normoxia reduces oxidative stress without increasing adverse events.See study design

What are the potential side effects?

Potential side effects are not specified but monitoring includes blood samples, head ultrasounds, and brain wave patterns to ensure safety and assess any negative outcomes related to the oxygen levels used.

T-NOX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby needs heart surgery with a special cooling technique before they are 30 days old.

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My heart has a condition where the main arteries are in the wrong position.

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I have low oxygen levels in my blood.

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I have a heart condition that causes blood to bypass my lungs.

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I have a complex heart condition from birth.

T-NOX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite outcome of major adverse events

Days alive and out of the intensive care unit (ICU) at 30 days after surgery

Global rank score

+3 more

T-NOX Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NormoxiaExperimental Treatment1 Intervention

On bypass, goal PaO2 on cardiopulmonary bypass of 60-100 mm Hg using lower fraction of inspired oxygen (FiO2) (blended sweep gas) via oxygenator Post-bypass, goal of PaO2 <100 mm Hg by anesthesia and in ICU via oxygen titration via mechanical ventilator for 24 hours post-op.

Group II: Standard of careActive Control1 Intervention

Frequent blood gases will be checked per protocol on bypass and correlated with the blood parameter monitoring system to maintain a PaO2 of 200-300 per standard practice

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,800 Previous Clinical Trials

6,379,111 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,257 Total Patients Enrolled

Nathaniel Sznycer-Taub, MDPrincipal Investigator - University of Michigan

University of Michigan C.S. Mott Children's Hospital, University of Michigan Hospital, Von Voigtlander Women's Hospital

Media Library

Normoxia (with controlled re-oxygenation) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04452188 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have volunteered to take part in this research endeavor?

"Affirmative. The details hosted on clinicaltrials.gov indicate that this medical trial, first posted in January 18th 2021, is currently recruiting participants. 42 individuals need to be sourced from a single site for the purpose of the study."

Answered by AI

Will the research team accept additional participants at this time?

"Indeed, the information posted on clinicaltrials.gov specifies that this medical investigation is still actively searching for participants. The research project was initially published on January 18th 2021 and was recently modified on June 22nd 2022; 42 individuals are being recruited from a single study site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

Nathaniel Sznycer-Taub 2021. "Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04452188.

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