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

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

Study Overview

• Status: Completed
• Conditions: Encephalopathy; Asphyxia Newborns

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria: Term infants

• Signed Informed consent

Exclusion Criteria:

• Known congenital anomalies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EES; Epidermal Electronic System
Hydrogel Electrode; Hydrogel based EEG electrode

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	60 minutes of life

Other Outcome Measures

Outcome Measure	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
Intubation at delivery	for meconium suctioning or ventilation purposes	Birth to 10 minutes of life
Positive Pressure Ventilation	By bag and mask or endotracheal tube	Birth to 10 minutes of life
Continuous Positive Airway Pressure		Birth to 10 minutes of life
Epinephrine administration		Birth to 10 minutes of life
Sodium bicarbonate administration		Birth to 10 minutes of life
Normal saline bolus administration		Birth to 10 minutes of life
Chest compressions		Birth to 10 minutes of life
Near-infrared spectroscopy measurement	Non-invasive brain tissue oximetry recording	Birth to 10 minutes of life. May extend to 60 minutes of life if applicable.

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: The Hartwell Foundation
• Investigators: Principal Investigator: Mary J Harbert, MD, Sharp Mary Birch Hospital for Women & Newborns

Publications and helpful links

General Publications

• Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8.
• 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.
• Massaro AN, Tsuchida T, Kadom N, El-Dib M, Glass P, Baumgart S, Chang T. aEEG evolution during therapeutic hypothermia and prediction of NICU outcome in encephalopathic neonates. Neonatology. 2012;102(3):197-202. doi: 10.1159/000339570. Epub 2012 Jul 12.
• Jacobs SE, Berg M, Hunt R, Tarnow-Mordi WO, Inder TE, Davis PG. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003311. doi: 10.1002/14651858.CD003311.pub3.
• Shalak LF, Laptook AR, Velaphi SC, Perlman JM. Amplitude-integrated electroencephalography coupled with an early neurologic examination enhances prediction of term infants at risk for persistent encephalopathy. Pediatrics. 2003 Feb;111(2):351-7. doi: 10.1542/peds.111.2.351.
• Kim DH, Lu N, Ma R, Kim YS, Kim RH, Wang S, Wu J, Won SM, Tao H, Islam A, Yu KJ, Kim TI, Chowdhury R, Ying M, Xu L, Li M, Chung HJ, Keum H, McCormick M, Liu P, Zhang YW, Omenetto FG, Huang Y, Coleman T, Rogers JA. Epidermal electronics. Science. 2011 Aug 12;333(6044):838-43. doi: 10.1126/science.1206157. Erratum In: Science. 2011 Sep 23;333(6050):1703.
• Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8.

Helpful Links

• cdc: Complications during pregnancy & birth are among leading causes of infant mortality

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2015
• Primary Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Perinatal depression
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Death; Brain Injuries; Brain Diseases; Asphyxia
• Other Study ID Numbers: Transition