Overview

This trial is active, not recruiting.

Conditions intrauterine growth restriction, premature - weight 1000g-2499g or gestation of 28-37weeks, neurodevelopmental disorder, eeg; spikes, centrotemporal, epilepsy of childhood
Treatment aeeg
Sponsor Medical University of Vienna
Start date June 2010
End date September 2013
Trial size 156 participants
Trial identifier NCT01942525, KKS-07-2013

Summary

Objective: The impact of intrauterine growth restriction (IUGR) on perinatal morbidity and long-term neurodevelopmental outcome has been published in numerous studies. Throughout this analysis, the influence of IUGR on the postnatal amplitude-integrated EEG (aEEG) in preterm infants below 30 weeks of gestation was assessed. The second concern was the correlation between the pattern of the aEEG in the first two weeks with neurodevelopmental outcome, comparing infants with and without IUGR.

Methods: Routinely assessed aEEG data of preterm infants with IUGR born below 30 weeks of gestation in the years 2005 until 2007 were analysed retrospectively according to the aEEG score (combining occurrence of sleep-wake-cycles, background activity and suspected seizure activity). Neurodevelopmental outcome was evaluated at 24 months using the Bayley Scales of Infant Development and standardized neurologic examination.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
birth weight <10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
aeeg aEEG
The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
control group with birth weight >10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up
aeeg aEEG
The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)

Primary Outcomes

Measure
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)
time frame: first 14 days of life

Secondary Outcomes

Measure
Neurodevelopmental outcome
time frame: 24 months

Eligibility Criteria

Male or female participants from 23 weeks up to 30 weeks old.

Inclusion Criteria: - preterm infants below 30 weeks of gestation Exclusion Criteria: - congenital anomalies - severe asphyxia

Additional Information

Official title Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants
Principal investigator Katrin Klebermass-Schrehof, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Medical University of Vienna.