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The Effect of Stimulating Substances on Brain Activity of Preterm Infants

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ClinicalTrials.gov Identifier: NCT01344317
Recruitment Status : Unknown
Verified October 2015 by Christine Czaba, Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : April 29, 2011
Last Update Posted : November 1, 2015
Sponsor:
Information provided by (Responsible Party):
Christine Czaba, Medical University of Vienna

Tracking Information
First Submitted Date April 27, 2011
First Posted Date April 29, 2011
Last Update Posted Date November 1, 2015
Study Start Date June 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Stimulating Substances on Brain Activity of Preterm Infants
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
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Preterm infants born below a gestational age of 30 weeks
Condition Apneas of Prematurity
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April¬†28,¬†2011)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2016
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

see above

Exclusion Criteria:

  • intraventricular hemorrhage
  • posthaemorrhagic hydrocephalus
  • cerebral infection
  • cerebral malformation
Sex/Gender
Sexes Eligible for Study: All
Ages 23 Weeks to 30 Weeks   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01344317
Other Study ID Numbers Nationalbankprojekt Nr.13660
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christine Czaba, Medical University of Vienna
Study Sponsor Medical University of Vienna
Collaborators Not Provided
Investigators
Principal Investigator: Manfred Weninger, MD, PhD Medical University of Vienna
PRS Account Medical University of Vienna
Verification Date October 2015