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NCT02445417 Clinical Trial

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

Encephalopathy Clinical Trial

Official title:
Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02445417
Other study ID # Transition
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 25, 2015

Study information
Verified date September 2018
Source Sharp HealthCare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date August 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Weeks to 44 Weeks
Eligibility Inclusion Criteria: Term infants

- Signed Informed consent

Exclusion Criteria:

- Known congenital anomalies

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Sharp Mary Birch Hospital for Women and Newborns San Diego California

Sponsors (2)
Lead Sponsor Collaborator
Sharp HealthCare The Hartwell Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

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;(1):CD003311. doi: 10.1002/14651858.CD003311.pub3. Review. — View Citation

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. — View Citation

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. Epub 2012 Jul 12. — View Citation

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. — View Citation

Pichler G, Avian A, Binder C, Zotter H, Schmölzer GM, Morris N, Müller 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. — View Citation

Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8. Review. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Apgar scores At 1, 5, 10, 15 and 20 minutes of life if done Birth to 10 minutes of life
Other Blowby oxygen at delivery Birth to 10 minutes of life
Other Intubation at delivery for meconium suctioning or ventilation purposes Birth to 10 minutes of life
Other Positive Pressure Ventilation By bag and mask or endotracheal tube Birth to 10 minutes of life
Other Continuous Positive Airway Pressure Birth to 10 minutes of life
Other Epinephrine administration Birth to 10 minutes of life
Other Sodium bicarbonate administration Birth to 10 minutes of life
Other Normal saline bolus administration Birth to 10 minutes of life
Other Chest compressions Birth to 10 minutes of life
Other 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.
Primary EEG recorded May be up to 60 minutes if applicable Birth to 10 minutes of life
Secondary Skin irritation from EES or hydrogel electrodes Redness, excoriation 60 minutes of life
Secondary Successful adhesion of EES to skin Redness, excoriation 60 minutes of life
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