NCT02451618

Brief Summary

For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

January 27, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

2.8 years

First QC Date

March 31, 2015

Last Update Submit

September 5, 2018

Conditions

SeizuresEncephalopathyAsphyxiated Newborn

Keywords

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

  • Seizure detection

    Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.

    24 hours

Secondary Outcomes (3)

  • EEG characterization

    24 hours

  • Skin integrity from standard EEG vs study electrodes

    24 hours

  • Hair removal from standard EEG vs study electrodes

    24 hours

Other Outcomes (5)

  • Apgar scores

    Birth to 10 minutes of life

  • Subject received hypothermia treatment within 6 hours of life

    Within 6 hours of life for 72 hours duration

  • Cause of seizure if known

    Participants will be followed for the duration of hospital stay, an average of 10 days.

  • +2 more other outcomes

Study Arms (2)

Epidermal Electronic System

EES, wireless tattoo electrode

Hydrogel electrode

EKG electrode, looking at hairline placement of electrodes.

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any newborn admitted to the NICU that requires an EEG for clinical care. Must be less than or equal to 44 weeks corrected gestational age.

You may qualify if:

  • Hospitalized neonates who already require continuous EEG recording for clinical care
  • Parents signed informed consent
  • CGA 44 weeks or less

You may not qualify if:

  • Patient is moribund

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 (9)

  • Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x.

    PMID: 12060001BACKGROUND

  • Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010.

    PMID: 20727485BACKGROUND

  • Isaeva E, Isaev D, Savrasova A, Khazipov R, Holmes GL. Recurrent neonatal seizures result in long-term increases in neuronal network excitability in the rat neocortex. Eur J Neurosci. 2010 Apr;31(8):1446-55. doi: 10.1111/j.1460-9568.2010.07179.x. Epub 2010 Apr 6.

    PMID: 20384780BACKGROUND

  • van Rooij LG, Toet MC, van Huffelen AC, Groenendaal F, Laan W, Zecic A, de Haan TR, van Straaten IL, Vrancken S, van Wezel G, van der Sluijs J, Ter Horst H, Gavilanes D, Laroche S, Naulaers G, de Vries LS. Effect of treatment of subclinical neonatal seizures detected with aEEG: randomized, controlled trial. Pediatrics. 2010 Feb;125(2):e358-66. doi: 10.1542/peds.2009-0136. Epub 2010 Jan 25.

    PMID: 20100767BACKGROUND

  • Nagarajan L, Ghosh S, Palumbo L. Ictal electroencephalograms in neonatal seizures: characteristics and associations. Pediatr Neurol. 2011 Jul;45(1):11-6. doi: 10.1016/j.pediatrneurol.2011.01.009.

    PMID: 21723453BACKGROUND

  • Ferree TC, Luu P, Russell GS, Tucker DM. Scalp electrode impedance, infection risk, and EEG data quality. Clin Neurophysiol. 2001 Mar;112(3):536-44. doi: 10.1016/s1388-2457(00)00533-2.

    PMID: 11222977BACKGROUND

  • Young GB, Campbell VC. EEG monitoring in the intensive care unit: pitfalls and caveats. J Clin Neurophysiol. 1999 Jan;16(1):40-5. doi: 10.1097/00004691-199901000-00003.

    PMID: 10082090BACKGROUND

  • 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

  • Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.

    BACKGROUND

MeSH Terms

Conditions

SeizuresBrain Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System Diseases

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 22, 2015

Study Start

January 27, 2015

Primary Completion

November 3, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

US(1)