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Trial NCT00136136

Resource URI: http://static.linkedct.org/resource/trials/NCT00136136
PropertyValue
linkedct:brief_title Validation of Bispectral Index (BIS)-Monitor in 3 Groups of Newborn Children
linkedct:condition <http://static.linkedct.org/resource/condition/1509>
linkedct:criteria Inclusion Criteria: - Group 1: normal healthy term newborns - Group 2: Ill term newborns without brain damage - Group 3: Preterm newborns without brain damage Exclusion Criteria: - Abnormal brain ultrasound - Abnormal neurological examination - Major congenital abnormalities - Use of analgesics, sedatives, antiepileptic drugs or curarisation
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date August 25, 2005
linkedct:has_dmc No
linkedct:id NCT00136136
rdfs:label Trial NCT00136136
linkedct:lastchanged_date April 27, 2009
linkedct:lead_sponsor_agency University Hospital, Ghent
linkedct:location <http://static.linkedct.org/resource/location/10332>
linkedct:nct_id NCT00136136
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 3 (xsd:int)
linkedct:official_title Validation of BIS-Monitor in 3 Groups of Newborn Children
linkedct:org_study_id 2003/139
linkedct:overall_contact_email kris.decoen@UGent.be
linkedct:overall_contact_last_name Kris De Coen, MD
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10165>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/272>
foaf:page <http://clinicaltrials.gov/show/NCT00136136>
linkedct:phase N/A
linkedct:source University Hospital, Ghent
linkedct:start_date August 2003
linkedct:study_design Other, Other
linkedct:study_type Observational
linkedct:summary This study will evaluate the registration of the bispectral index and spectral edge frequency in relation to the behavioural state.
rdf:type linkedct:trials
linkedct:verification_date April 2009