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
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Tracking Information | ||||
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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. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
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Sex/Gender |
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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 |
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PRS Account | Medical University of Vienna | |||
Verification Date | October 2015 |