Brain Activity During Birth for Prediction of Newborns at... | NCT02445417

Studies
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

NCT02445417

Sponsor

Sharp HealthCare

Status

Completed

Last Update Posted

Sep 7, 2018Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Encephalopathy
Asphyxia Newborns

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2015Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Not provided

First Submitted Date

Mar 31, 2015

First Submission Date that Met QC Criteria

May 12, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2018

Last Update Posted Date

Sep 7, 2018Actual

Name	Class
The Hartwell Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is early identification of asphyxiated newborns through eeg starting in the delivery room.

Detailed Description

There is a need for a reliable detector of birth asphyxia so that newborns with birth asphyxia can have timely and accurate diagnosis to receive therapeutic hypothermia within 6 hrs of life, which has been shown to significantly reduce deaths and improve long term developmental outcomes.

This study is designed to record EEG during birth transition through the first 10 minutes of life.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EES		Epidermal Electronic System
Hydrogel Electrode		Hydrogel based EEG electrode

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EEG recorded	May be up to 60 minutes if applicable	Birth to 10 minutes of life

Secondary Outcomes

Measure	Description	Time Frame
Skin irritation from EES or hydrogel electrodes	Redness, excoriation	60 minutes of life
Successful adhesion of EES to skin	Redness, excoriation

Other Outcomes

Measure	Description	Time Frame
Apgar scores	At 1, 5, 10, 15 and 20 minutes of life if done	Birth to 10 minutes of life
Blowby oxygen at delivery		Birth to 10 minutes of life

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Term infants

Signed Informed consent

Exclusion Criteria:

Known congenital anomalies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

36 Weeks

Maximum Age

44 Weeks

Standard Ages

Child

Study Population

Term infants at delivery (37-44 weeks gestational age)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mary J Harbert, MD	Sharp Mary Birch Hospital for Women & Newborns	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sharp Mary Birch Hospital for Women and Newborns		San Diego	California	92123	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21524031	Background	Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8.
23498155	Background	Perez A, Ritter S, Brotschi B, Werner H, Caflisch J, Martin E, Latal B. Long-term neurodevelopmental outcome with hypoxic-ischemic encephalopathy. J Pediatr. 2013 Aug;163(2):454-9. doi: 10.1016/j.jpeds.2013.02.003. Epub 2013 Mar 14.

ID	Term
D001927	Brain Diseases
D001238	Asphyxia Neonatorum

ID	Term
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities