Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants (NEOBRAIN)
This study has been completed.
Sponsor:
Hannover Medical School
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
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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
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 Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
Wounds and Injuries Neuroprotective Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012
