eonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants (NEOBRAIN)

Completed

Conditions: preterm birth
10010335
10028920

Registration Number: NL-OMON31644

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

preterm infants born with a gestational age below 28 completed weeks.

Exclusion Criteria

preterm infants born after 28 completed weeks or born at a referring hospital rather than in the UMC Utrecht
congenital anomalies
chormosomal disorders

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures: Brain white matter damage (WMD, defined by MRI, US,<br /><br>EEG)<br /><br>There is no single parameter that can be seen as an endpoint in this clinical<br /><br>part of the study. All the different biomarkers (EEG/ proteomics and<br /><br>metabolomics) will be investigated for being the best predictive marker for<br /><br>white matter injury that will be seen on the MRI performed at the term<br /><br>equivalent age. Following on to this, it will be studied whether these markers<br /><br>will also be predictive for the neurodevelopmental outcome as tested at two<br /><br>years of age with a BSID-III.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Developmental assessment at 2 years of age, using a full neurological<br /><br>examination and the BSID-III<br /><br>All children will be seen in the follow-up clinic, which is routinely done<br /><br>within the scope of the LNF (Landelijk Nederlandse Follow-up).</p><br>