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

NCT01942525 | Unknown

• 1 other identifier: KKS-07-2013
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

IUGR; aEEG; preterm infants; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Neurodevelopmental outcome

  24 months

Other Outcomes (1)

• Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls

  24 months

Study Arms (2)

Intrauterine growth restriction

birth weight \<10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up

Other: aEEG

Appropriate for gestation age

control group with birth weight \>10th percentile first intervention: aEEG second intervention: assessment of neurodevelopmental follow-up

Other: aEEG

Interventions

aEEG OTHER

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

Also known as: assessment of neurodevelopmental follow-up

Appropriate for gestation age; Intrauterine growth restriction

Eligibility Criteria

• Age: 23 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Retrospectively, children with intrauterine growth restriction (defined as a birth weight below the 10th percentile) treated at the Neonatal Intensive Care Unit (NICU) of the Medical University Vienna between 2005 and 2007 were included in the study. Besides IUGR, inclusion criteria were gestational age between 23+1 and 29+6 weeks and routinely assessed aEEG measurements. Infants with congenital anomalies and severe asphyxia were excluded. The control group consists of infants of the same age with normal birth weight (\>10th percentile) in the same study period.

You may qualify if:

• preterm infants below 30 weeks of gestation

You may not qualify if:

• congenital anomalies
• severe asphyxia

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Fetal Growth Retardation; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Katrin Klebermass-Schrehof, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 24, 2013
• First Posted: September 16, 2013
• Study Start: June 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 16, 2013

Record last verified: 2013-09

Locations

AU (1)