Clinical trial NCT02445417: Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
Official title: Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalopathy
Asphyxia Newborns
Keywords: Perinatal depression
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: The Hartwell Foundation
First posted: 2015-05-15
Enrollment: 60
Sex: ALL
Minimum age (years): 36
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term infants at delivery (37-44 weeks gestational age)

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.

Eligibility criteria: Inclusion Criteria: Term infants

* Signed Informed consent

Exclusion Criteria:

* Known congenital anomalies

Primary outcomes:
measure: EEG recorded
timeFrame: Birth to 10 minutes of life
Secondary outcomes:
measure: Skin irritation from EES or hydrogel electrodes
timeFrame: 60 minutes of life
measure: Successful adhesion of EES to skin
timeFrame: 60 minutes of life
Other outcomes:
measure: Apgar scores
timeFrame: Birth to 10 minutes of life
measure: Blowby oxygen at delivery
timeFrame: Birth to 10 minutes of life
measure: Intubation at delivery
timeFrame: Birth to 10 minutes of life
measure: Positive Pressure Ventilation
timeFrame: Birth to 10 minutes of life
measure: Continuous Positive Airway Pressure
timeFrame: Birth to 10 minutes of life
measure: Epinephrine administration
timeFrame: Birth to 10 minutes of life
measure: Sodium bicarbonate administration
timeFrame: Birth to 10 minutes of life
measure: Normal saline bolus administration
timeFrame: Birth to 10 minutes of life
measure: Chest compressions
timeFrame: Birth to 10 minutes of life
measure: Near-infrared spectroscopy measurement
timeFrame: Birth to 10 minutes of life. May extend to 60 minutes of life if applicable.
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Mary J Harbert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raghuveer TS, Cox AJ. Neonatal resuscitation: an update. Am Fam Physician. 2011 Apr 15;83(8):911-8.
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.
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. doi: 10.1159/000339570. Epub 2012 Jul 12.
citation: 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.
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. doi: 10.1542/peds.111.2.351.
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.
citation: 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.