NCT02698020

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

2.7 years

First QC Date

February 25, 2016

Last Update Submit

October 10, 2018

Conditions

Oxygen ToxicityOxidative Stress

Keywords

NewbornAnesthesiaOxygenHyperoxia

Outcome Measures

Primary Outcomes (1)

  • Transcutaneous and blood-gas pO2

    Area under curve (AUC) and absolute values of pO2

    30 min

Secondary Outcomes (3)

  • Cerebral Oximetry

    30 min

  • Atelectasis

    30 min

  • Isoprostane

    4 h

Study Arms (2)

Control

NO INTERVENTION

High level of supplemental inspired oxygen

Room-air

EXPERIMENTAL

Supplemental oxygen only provided if oxygen saturation below target

Procedure: Room-air

Interventions

Room-airPROCEDURE

Provision of room-air

Room-air

Eligibility Criteria

AgeUp to 4 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
1. Newborn less than 44 weeks postconceptional age 2. No pulmonary disease, no oxygen requirement, or assisted ventilation 3. No genetic syndrome

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital, Pediatric anesthesia Unit

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johan Agren, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 3, 2016

Study Start

November 1, 2015

Primary Completion

July 30, 2018

Study Completion

October 10, 2018

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations

SE(1)