The Effect of Stimulating Substances on Brain Activity of Preterm Infants
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|ClinicalTrials.gov Identifier: NCT01344317|
Recruitment Status : Unknown
Verified October 2015 by Christine Czaba, Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : April 29, 2011
Last Update Posted : November 2, 2015
Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas of prematurity. Both substances have effects on the central nervous system. While there are data available concerning the use of caffeine (the methylxanthine used at our NICU) even proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are data which suggest a negative effect of the central stimulants doxapram on longterm outcome in this group of infants. Nevertheless concerning both medications only few studies have been published and only scarce data are available concerning the effect of these medications on brain activity of very preterm infants until now.
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.
|Condition or disease|
|Apneas of Prematurity|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||The Effect of Stimulating Substances on Brain Activity Measured by Amplitude-integrated EEG and Long-term Neurodevelopmental Outcome of Preterm Infants Born Below 30 Weeks of Gestation|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||November 2010|
|Estimated Study Completion Date :||June 2016|
Premature infants below 30 weeks of gestation who receive Caffeine treatment
Caffeine and Doxapram group
Premature infants below 30 weeks of gestation who receive Caffeine and Doxapram treatment
Group with no treatment
Premature infants below 30 weeks of gestation with no stimulating treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344317
|Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology|
|Vienna, Austria, 1090|
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Manfred Weninger, MD, PhD||Medical University of Vienna|