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

Intrauterine Growth Restriction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01942525
• Other study ID #: KKS-07-2013
• Status: Active, not recruiting
• Phase: N/A
• First received: August 24, 2013
• Last updated: September 13, 2013
• Start date: June 2010
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Weeks to 30 Weeks

Eligibility

Inclusion Criteria:

• preterm infants below 30 weeks of gestation

Exclusion Criteria:

• congenital anomalies

• severe asphyxia

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• EEG; Spikes, Centrotemporal, Epilepsy of Childhood
• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Mental Disorders Diagnosed in Childhood
• Neurodevelopmental Disorder
• Premature - Weight 1000g-2499g or Gestation of 28-37weeks

Intervention

Other:
• aEEG
The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls	morbidities until discharge (Intraventricular hemorrhage, retinopathy, chronic lung disease, necrotizing enterocolitis, periventricular leucomalacia); mortality and neurodevelopmental outcome (via Bayley Scales of Infant Development >85= normal, <70 = severly impaired)	24 months	No
Primary	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	No
Secondary	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	No