Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

Brain Damage, Chronic Clinical Trial

— NEOBRAIN  

Official title:

Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544895
• Other study ID #: LSHM-CT-2006-036534
• Status: Completed
• Phase: N/A
• First received: October 12, 2007
• Last updated: June 22, 2011
• Start date: October 2007
• Est. completion date: October 2010

Study information

• Verified date: June 2011
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Gestational age < 28 weeks

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Damage, Chronic
• Brain Injuries

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck	Innsbruck
France	Hôpital Robert Debré	Paris
Germany	Charité, Campus Virchow Klinikum	Berlin
Germany	Universität Duisburg-Essen	Essen
Germany	Hannover Medical School	Hannover
Italy	Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.	Milano
Italy	Azienda Ospedaliera Universitaria Senese	Siena
Netherlands	Wilhelmina Children's Hospital	Utrecht
Sweden	Perinatal Center	Gothenburg
Sweden	University Hospital	Lund
Sweden	Academic Children's Hospital	Uppsala
Switzerland	Hôpital des Enfants	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	European Commission

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Netherlands,  Sweden,  Switzerland, 

References & Publications (1)

Dammann O, Cesario A, Hallen M. NEOBRAIN--an EU-funded project committed to protect the newborn brain. Neonatology. 2007;92(4):217-8. Epub 2007 May 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain white matter damage (WMD, defined by MRI ,US, EEG)		during stay in NICU and until discharge	No
Secondary	Developmental assessment		at 2 years of age	No

External Links

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