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The Effect of Stimulating Substances on Brain Activity of Preterm Infants

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christine Czaba, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01344317
First received: April 27, 2011
Last updated: October 30, 2015
Last verified: October 2015
History of Changes

April 27, 2011
October 30, 2015
June 2009
November 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01344317 on ClinicalTrials.gov Archive Site
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The Effect of Stimulating Substances on Brain Activity of Preterm Infants
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

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Preterm infants born below a gestational age of 30 weeks
Apneas of Prematurity
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  • Caffeine group
    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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2016
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

see above

Exclusion Criteria:

  • intraventricular hemorrhage
  • posthaemorrhagic hydrocephalus
  • cerebral infection
  • cerebral malformation
Both
23 Weeks to 30 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01344317
Nationalbankprojekt Nr.13660
No
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Christine Czaba, Medical University of Vienna
Medical University of Vienna
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Principal Investigator: Manfred Weninger, MD, PhD Medical University of Vienna
Medical University of Vienna
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP