Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

NCT ID: NCT02698020

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-10-10

Brief Summary

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

Detailed Description

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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.

Conditions

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Oxygen Toxicity Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

High level of supplemental inspired oxygen

Group Type NO_INTERVENTION

No interventions assigned to this group

Room-air

Supplemental oxygen only provided if oxygen saturation below target

Group Type EXPERIMENTAL

Room-air

Intervention Type PROCEDURE

Provision of room-air

Interventions

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Room-air

Provision of room-air

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Agren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Women's and Children's Health, Uppsala University

Locations

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Uppsala University Hospital, Pediatric anesthesia Unit

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ANOXneo

Identifier Type: -

Identifier Source: org_study_id

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