The Effect of Stimulating Substances on Brain Activity of Preterm Infants
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Apneas of Prematurity
Phase: N/A
Status: Recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Manfred Weninger, MD, PhD, Principal Investigator, Affiliation: Medical University of Vienna
Overall contact:
Christine Czaba, MD, Phone: 004340400, Ext: 2930, Email: Christine.Czaba@meduniwien.ac.at
Summary
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Eligibility
Minimum age: 23 Weeks.
Maximum age: 30 Weeks.
Gender(s): Both.
Criteria:
Inclusion Criteria:
see above
Exclusion Criteria:
- intraventricular hemorrhage
- posthaemorrhagic hydrocephalus
- cerebral infection
- cerebral malformation
Locations and Contacts
Christine Czaba, MD, Phone: 004340400, Ext: 2930, Email: Christine.Czaba@meduniwien.ac.at
Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology, Vienna 1090, Austria; Completed
Medical University of Vienna, Vienna 1090, Austria; Recruiting
Arnold Pollak, MD, PhD, Phone: 004340400, Ext: 3224, Email: arnold.pollak@meduniwien.ac.at
Christine Czaba, MD, Principal Investigator
Katrin Klebermaß-Schrehof, MD, Sub-Investigator
Manfred Weninger, MD, PhD, Sub-Investigator
Additional Information
Starting date: June 2009
Last updated: April 28, 2011
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