Influence of Intrauterine Growth Restriction on Amplitude-integrated EEG in Preterm Infants

Study Overview
=================
Brief 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.

Official Title
-----------------
Intrauterine Growth Restriction Has an Impact on Amplitude-integrated EEG in Preterm Infants

Conditions
-----------------
Intrauterine Growth Restriction, Premature - Weight 1000g-2499g or Gestation of 28-37weeks, Neurodevelopmental Disorder, EEG; Spikes, Centrotemporal, Epilepsy of Childhood

Intervention / Treatment
-----------------
* Other: aEEG


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

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 30 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intrauterine growth restriction<br>birth weight <10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up | Other: aEEG<br>* The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)<br>* Other names: assessment of neurodevelopmental follow-up;|
| Appropriate for gestation age<br>control group with birth weight >10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up | Other: aEEG<br>* The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)<br>* Other names: assessment of neurodevelopmental follow-up;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity) | composite score background activity (BA), occurrence of sleep-wake-cycling (SWC) and presence of seizure activity (SA) meaning score 1= normal (normal BA, SWC yes, SA no) and score 2 and 3 = abnormal (2=abnormality in 1 category (BA, SWC or SA) and score 3= abnormality in 2 or 3 categories | first 14 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental outcome | composite score: Bayley Scales of Infant Development (>85= normal, <70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal) | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUGR, aEEG, preterm infants, neurodevelopmental outcome