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

Summary

This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.

In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored.

The hypotheses of this trial are:

* that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group
* there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups.
* the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery

Conditions

• Hypoplastic Left Heart Syndrome
• Total Anomalous Pulmonary Venous Return
• Truncus Arteriosus
• Pulmonary Atresia With Ventricular Septal Defect
• Transposition of the Great Arteries
• Double Outlet Right Ventricle, Subpulmonary VSD
• Tetralogy of Fallot
• Double Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary Stenosis
• Cardiopulmonary Bypass

Interventions

OTHER

Normoxia (with controlled re-oxygenation)

Participants will receive lower levels of oxygen during surgery and after surgery on the ventilator. As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation with an FiO2 of 50% or less (unless clinically necessary) to achieve oxygen saturation and PaO2 goals that fit within the expected range for the participant's physiology: 1. Single ventricle patients (PaO2:35-45 and oxygen saturation 75%-85%) 2. Two ventricle patients (PaO2: 60-100 and oxygen saturation \>92%)

OTHER

Standard of care ventilation

As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation per standard protocols. Ventilation will be continued in the ICU and adjusted per standard goals per the intensivist.

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• University of Michigan

  lead OTHER

Principal Investigators

• Nathaniel Sznycer-Taub, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

29 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-18

Primary Completion

2023-04-20

Completion

2023-04-20

Countries

• United States

Study Locations