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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544895
First Posted: October 16, 2007
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
European Commission
Information provided by:
Hannover Medical School
  Purpose
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)

Condition
Brain Damage, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

Further study details as provided by Hannover Medical School:

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

Secondary Outcome Measures:
  • Developmental assessment [ Time Frame: at 2 years of age ]

Biospecimen Retention:   Samples With DNA
whole blood, urine

Estimated Enrollment: 600
Study Start Date: October 2007
Study Completion Date: October 2010
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Preterm newborns with a gestational age < 28wks
Criteria

Inclusion Criteria:

  • Gestational age < 28 weeks
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544895


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

Publications:
Responsible Party: Prof. Dr. med. Olaf Dammann, Perinatal Infectious Disease Epidemiology Unit - Medical School Hannover
ClinicalTrials.gov Identifier: NCT00544895     History of Changes
Other Study ID Numbers: LSHM-CT-2006-036534
First Submitted: October 12, 2007
First Posted: October 16, 2007
Last Update Posted: June 23, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs