The Effect of Stimulating Substances on Brain Activity of Preterm Infants

Tracking Information
First Submitted Date	April 27, 2011
First Posted Date	April 29, 2011
Last Update Posted Date	November 2, 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	Complete list of historical versions of study NCT01344317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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