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

June 22, 2011 updated by: Hannover Medical School
NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
  • France
      • Paris, France, F-75019
        • Hôpital Robert Debré
  • Germany
      • Berlin, Germany, 13353
        • CHARITÉ, Campus Virchow Klinikum
      • Essen, Germany, 45122
        • Universität Duisburg-Essen
      • Hannover, Germany, 30625
        • Hannover Medical School
  • Italy
      • Milano, Italy
        • Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.
      • Siena, Italy, 53100
        • Azienda Ospedaliera Universitaria Senese
  • Netherlands
      • Utrecht, Netherlands, 3508 AB
        • Wilhelmina Children's Hospital
  • Sweden
      • Gothenburg, Sweden, 41685
        • Perinatal Center
      • Lund, Sweden, 22185
        • University Hospital
      • Uppsala, Sweden, 75185
        • Academic Children's Hospital
  • Switzerland
      • Geneva, Switzerland, 1211
        • Hôpital des Enfants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm newborns with a gestational age < 28wks

Description

Inclusion Criteria:

  • Gestational age < 28 weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brain white matter damage (WMD, defined by MRI ,US, EEG)
Time Frame: during stay in NICU and until discharge
during stay in NICU and until discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Developmental assessment
Time Frame: at 2 years of age
at 2 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

European Commission

Investigators

  • Study Director: Olaf Dammann, Medical School Hannover

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

October 12, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

June 23, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSHM-CT-2006-036534

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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