NCT02445417

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 25, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

March 31, 2015

Last Update Submit

September 5, 2018

Conditions

EncephalopathyAsphyxia Newborns

Keywords

Perinatal depression

Outcome Measures

Primary Outcomes (1)

  • EEG recorded

    May be up to 60 minutes if applicable

    Birth to 10 minutes of life

Secondary Outcomes (2)

  • Skin irritation from EES or hydrogel electrodes

    60 minutes of life

  • Successful adhesion of EES to skin

    60 minutes of life

Other Outcomes (10)

  • Apgar scores

    Birth to 10 minutes of life

  • Blowby oxygen at delivery

    Birth to 10 minutes of life

  • Intubation at delivery

    Birth to 10 minutes of life

  • +7 more other outcomes

Study Arms (2)

EES

Epidermal Electronic System

Hydrogel Electrode

Hydrogel based EEG electrode

Eligibility Criteria

Age36 Weeks - 44 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Signed Informed consent

You may not qualify if:

  • Known congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (7)

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

    PMID: 21524031BACKGROUND

  • 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.

    PMID: 23498155BACKGROUND

  • 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.

    PMID: 22796967BACKGROUND

  • 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.

    PMID: 23440789BACKGROUND

  • 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.

    PMID: 12563063BACKGROUND

  • 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.

    PMID: 21836009BACKGROUND

  • 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.

    PMID: 23313424BACKGROUND

Related Links

MeSH Terms

Conditions

Brain DiseasesAsphyxia Neonatorum

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mary J Harbert, MD

    Sharp Mary Birch Hospital for Women & Newborns

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Neonatal Neurology

Study Record Dates

First Submitted

March 31, 2015

First Posted

May 15, 2015

Study Start

June 25, 2015

Primary Completion

August 31, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

US(1)