Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01942525
Enrollment
156
Registered
2013-09-16
Start date
2010-06-30
Completion date
2013-09-30
Last updated
2013-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

IUGR, aEEG, preterm infants, neurodevelopmental outcome

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.

Interventions

OTHERaEEG

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

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
23 Weeks to 30 Weeks
Healthy volunteers
No

Inclusion criteria

* preterm infants below 30 weeks of gestation

Exclusion criteria

* congenital anomalies * severe asphyxia

Design outcomes

Primary

MeasureTime frameDescription
aEEG score (including background pattern, occurrence of sleep-wake-cycling and presence of seizure activity)first 14 days of lifecomposite 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

Secondary

MeasureTime frameDescription
Neurodevelopmental outcome24 monthscomposite score: Bayley Scales of Infant Development (\>85= normal, \<70 severely impaired, 71-84= mildly impaired) and standardized neurologic examination (normal or abnormal)

Other

MeasureTime frameDescription
Morbidity, mortality and neurodevelopmental outcome of patients with IUGR compared to controls24 monthsmorbidities 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)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026