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The Effect of Stimulating Substances on Brain Activity of Preterm Infants

NCT01344317 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2015-11-02

No results posted yet for this study

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.

Conditions

  • Apneas of Prematurity

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Manfred Weninger, MD, PhD · Medical University of Vienna

Eligibility

Min Age
23 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-11-30
Completion
2016-06-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01344317 on ClinicalTrials.gov