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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31644

Enrollment

100

Registered

2008-03-04

Start date

2008-05-27

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

preterm birth

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results