Skip to main content
OpenTrials
Completed

NCT Number: NCT02698020

Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Oxygen Toxicity Hyperoxia Oxidative Stress Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Pediatric anesthesia Unit

Uppsala, 75185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Newborn less than 44 weeks postconceptional age
  • No pulmonary disease, no oxygen requirement, or assisted ventilation
  • No genetic syndrome

Treatment and study plan

Room-air

Procedure

Provision of room-air

Primary outcomes

  1. Transcutaneous and blood-gas pO2

    Time frame: 30 min

    Area under curve (AUC) and absolute values of pO2

Secondary outcomes

  1. Cerebral Oximetry

    Time frame: 30 min

    AUC of O2 saturation

  2. Atelectasis

    Time frame: 30 min

    Reduced lung compliance as a measure of atelectasis formation

  3. Isoprostane

    Time frame: 4 h

    Level of isoprostanes in blood and urine

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Acronym: ANOXneo

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.