Apneas of Prematurity Clinical Trial
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
| Verified date | October 2015 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 60 |
| Est. completion date | June 2016 |
| Est. primary completion date | November 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 23 Weeks to 30 Weeks |
| Eligibility |
Inclusion Criteria: see above Exclusion Criteria: - intraventricular hemorrhage - posthaemorrhagic hydrocephalus - cerebral infection - cerebral malformation |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna | |
| Austria | Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,