Optimized Oxygen Delivery During General Anesthesia in Newborn Infants (ANOXneo)

October 10, 2018 updated by: Uppsala University

Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.

An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital, Pediatric anesthesia Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Newborn less than 44 weeks postconceptional age
  2. No pulmonary disease, no oxygen requirement, or assisted ventilation
  3. No genetic syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
High level of supplemental inspired oxygen
Experimental: Room-air
Supplemental oxygen only provided if oxygen saturation below target
Procedure: Room-air
Provision of room-air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcutaneous and blood-gas pO2
Time Frame: 30 min
Area under curve (AUC) and absolute values of pO2
30 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Oximetry
Time Frame: 30 min
AUC of O2 saturation
30 min
Atelectasis
Time Frame: 30 min
Reduced lung compliance as a measure of atelectasis formation
30 min
Isoprostane
Time Frame: 4 h
Level of isoprostanes in blood and urine
4 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Johan Agren, MD, PhD, Department of Women's and Children's Health, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

July 30, 2018

Study Completion (Actual)

October 10, 2018

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANOXneo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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