The Effect of Stimulating Substances on Brain Activity of Preterm Infants
Recruitment status was Recruiting
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.
Apneas of Prematurity
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
|Estimated Study Completion Date:||November 2012|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344317
|Contact: Christine Czaba, MD||004340400 ext 2930||Christine.Czaba@meduniwien.ac.at|
|Contact: Katrin Klebermaß-Schrehof, Md||004340400 ext firstname.lastname@example.org|
|Medical University of Vienna||Recruiting|
|Vienna, Austria, 1090|
|Contact: Arnold Pollak, MD, PhD 004340400 ext 3224 email@example.com|
|Principal Investigator: Christine Czaba, MD|
|Sub-Investigator: Katrin Klebermaß-Schrehof, MD|
|Sub-Investigator: Manfred Weninger, MD, PhD|
|Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology||Completed|
|Vienna, Austria, 1090|
|Principal Investigator:||Manfred Weninger, MD, PhD||Medical University of Vienna|