Trials Sponsors Conditions Drugs Pricing

Conditions

Electroencephalography General Anesthesia Pediatric Anesthesia

Keywords

EEGElectroencephalographyPediatric anesthesia

Outcome Measures

Primary Outcomes (1)

Incidence of isoelectric EEG events in young children.
Isoelectric EEG event is defined as low amplitude EEG for ≥ 2 seconds simultaneously across all 4 EEG channels.
Up to 6 months after EEG recording

Secondary Outcomes (13)

Discontinuity of isoelectric EEG events among age groups
Up to 12 months after EEG recording.
Association of isoelectric EEG events between gender groups
Up to 12 months after EEG recording
Patient Weight associated with isoelectric EEG events
Up to 12 months after EEG recording
Changes in patient's physical status associated with isoelectric EEG events
Up to 12 months after EEG recording
Patient Gestational Age associated with isoelectric EEG events
Up to 12 months after EEG recording
+8 more secondary outcomes

Study Arms (1)

Children: 0-36mo

EEG sensor will be placed on the subject's forehead to observe and record EEG activity. No other applicable intervention.

Eligibility Criteria

AgeUp to 36 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Sampling MethodProbability Sample

Study Population

0-36 month old children undergoing general anesthesia for surgery.

You may qualify if:

Age 0 to 36 (inclusive) months

Sponsors & Collaborators

Children's Hospital Medical Center, Cincinnati
Othercollaborator
Yuying Children's Hospital of Wenzhou Medical University
Othercollaborator

Study Sites (15)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Royal Children's Hospital (RCH, Melbourne, Australia)

Parkville, Victoria, 3052, Australia

Princess Margaret Hospital for Children (PMH, Perth, Australia)

Subiaco, Western Australia, 6008, Australia

Beijing Children's Hospital/Capital Medical University

Study Officials

Paula Hu
Clinical Research Manager
STUDY DIRECTOR
Justin Skowno
Sydney Children's Hospitals Network
PRINCIPAL INVESTIGATOR
Andrew J Davidson
Royal Children's Hospital
PRINCIPAL INVESTIGATOR
Britta Regli-von Ungern-Sternberg
Princess Margaret Hospital for Children, Perth, Australia
PRINCIPAL INVESTIGATOR

Enrollment

687 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 2, 2018

First Posted

February 14, 2018

Study Start

June 21, 2018

Actual (reported)

Multi-center Isoelectric EEG Study in Children Under General Anesthesia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

Children: 0-36mo

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

Children: 0-36mo

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations