This trial is active, not recruiting.

Condition apneas of prematurity
Sponsor Medical University of Vienna
Start date June 2009
End date November 2010
Trial size 60 participants
Trial identifier NCT01344317, Nationalbankprojekt Nr.13660


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Premature infants below 30 weeks of gestation who receive Caffeine treatment
Premature infants below 30 weeks of gestation who receive Caffeine and Doxapram treatment
Premature infants below 30 weeks of gestation with no stimulating treatment

Eligibility Criteria

Male or female participants from 23 weeks up to 30 weeks old.

Inclusion Criteria: see above Exclusion Criteria: - intraventricular hemorrhage - posthaemorrhagic hydrocephalus - cerebral infection - cerebral malformation

Additional Information

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
Principal investigator Manfred Weninger, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Medical University of Vienna.