The Effect of Stimulating Substances on Brain Activity of Preterm Infants
NCT ID: NCT01344317
Last Updated: 2015-11-02
Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2009-06-30
2016-06-30
Brief Summary
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The aim of this study: is the assessment of the effect of stimulating substances on brain activity of preterm infants born below 30 weeks of gestation and their longterm neurodevelopmental follow-up.
Methods: This study is a prospective study including preterm infants born below 30 weeks of gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG). The first aEEG measurement is performed without caffeine and/or doxapram medication. At least one hour of brain activity is registrated. The second measurement is done at least 24 hours after the start of caffeine and/ or doxapram treatment.
The percentage of different background patterns, the occurrence and duration of sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed. Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of the Bayley Scales of Infant Development II and standardized clinical neurological examination.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Caffeine group
Premature infants below 30 weeks of gestation who receive Caffeine treatment
No interventions assigned to this group
Caffeine and Doxapram group
Premature infants below 30 weeks of gestation who receive Caffeine and Doxapram treatment
No interventions assigned to this group
Group with no treatment
Premature infants below 30 weeks of gestation with no stimulating treatment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* posthaemorrhagic hydrocephalus
* cerebral infection
* cerebral malformation
23 Weeks
30 Weeks
ALL
Yes
Sponsors
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Medical University of Vienna
OTHER
Responsible Party
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Christine Czaba
Dr.med.univ.
Principal Investigators
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Manfred Weninger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology
Vienna, Vienna, Austria
Medical University of Vienna
Vienna, Vienna, Austria
Countries
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Other Identifiers
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Nationalbankprojekt Nr.13660
Identifier Type: -
Identifier Source: org_study_id
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