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The Effect of Stimulating Substances on Brain Activity of Preterm Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Christine Czaba, Medical University of Vienna.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344317
First Posted: April 29, 2011
Last Update Posted: November 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christine Czaba, Medical University of Vienna
  Purpose

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.


Condition
Apneas of Prematurity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Christine Czaba, Medical University of Vienna:

Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: June 2016
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants born below a gestational age of 30 weeks
Criteria

Inclusion Criteria:

see above

Exclusion Criteria:

  • intraventricular hemorrhage
  • posthaemorrhagic hydrocephalus
  • cerebral infection
  • cerebral malformation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344317


Locations
Austria
Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Neonatology
Vienna, Austria, 1090
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Manfred Weninger, MD, PhD Medical University of Vienna
  More Information

Responsible Party: Christine Czaba, Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01344317     History of Changes
Other Study ID Numbers: Nationalbankprojekt Nr.13660
First Submitted: April 27, 2011
First Posted: April 29, 2011
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents