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

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00544895
First received: October 12, 2007
Last updated: June 22, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Developmental assessment [ Time Frame: at 2 years of age ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, urine


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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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
Study First Received: October 12, 2007
Last Updated: June 22, 2011
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on October 23, 2014