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

U

Uppsala University

Status

Completed

Conditions

Oxygen Toxicity
Oxidative Stress

Treatments

Procedure: Room-air

Study type

Interventional

Funder types

Other

Identifiers

NCT02698020
ANOXneo

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

Under 4 weeks old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Control
No Intervention group
Description:
High level of supplemental inspired oxygen
Room-air
Experimental group
Description:
Supplemental oxygen only provided if oxygen saturation below target
Treatment:
Procedure: Room-air

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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