ANOXneo: Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

• Sponsor: Uppsala University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02698020
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oxygen Toxicity; Oxidative Stress	Procedure: Room-air	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Oxygen Delivery During General Anesthesia in Newborn Infants: An Open Randomized Controlled Trial of Two Levels of Inspired Oxygen.
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Jul 30, 2018
• Actual Study Completion Date: Oct 10, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Transcutaneous and blood-gas pO2 [30 min]

   Area under curve (AUC) and absolute values of pO2

Secondary Outcome Measures

1. Cerebral Oximetry [30 min]

   AUC of O2 saturation

2. Atelectasis [30 min]

   Reduced lung compliance as a measure of atelectasis formation

3. Isoprostane [4 h]

   Level of isoprostanes in blood and urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 4 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Newborn less than 44 weeks postconceptional age

2. No pulmonary disease, no oxygen requirement, or assisted ventilation

3. No genetic syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital, Pediatric anesthesia Unit	Uppsala		Sweden	75185

Sponsors and Collaborators

• Uppsala University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT02698020
• Other Study ID Numbers: ANOXneo
• First Posted: Mar 3, 2016
• Last Update Posted: Oct 15, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Uppsala University: Newborn; Anesthesia; Oxygen; Hyperoxia

Study Results

No Results Posted as of Oct 15, 2018