The Effect of Stimulating Substances on Brain Activity of Preterm Infants

• ClinicalTrials.gov Identifier: NCT01344317
• Recruitment Status: Unknown
• First Posted: April 29, 2011
• Last Update Posted: November 1, 2015
• Sponsor: Medical University of Vienna
• 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
• 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

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

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