NCT00544895

Brief 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)

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Geographic Reach
7 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

First QC Date

October 12, 2007

Last Update Submit

June 22, 2011

Conditions

Brain Damage, Chronic

Outcome Measures

Primary Outcomes (1)

  • Brain white matter damage (WMD, defined by MRI ,US, EEG)

    during stay in NICU and until discharge

Secondary Outcomes (1)

  • Developmental assessment

    at 2 years of age

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Preterm newborns with a gestational age \< 28wks

You may qualify if:

  • Gestational age \< 28 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Hôpital Robert Debré

Paris, F-75019, France

Location

Charité, Campus Virchow Klinikum

Berlin, 13353, Germany

Location

Universität Duisburg-Essen

Essen, 45122, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.

Milan, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

Wilhelmina Children's Hospital

Utrecht, 3508 AB, Netherlands

Location

Perinatal Center

Gothenburg, 41685, Sweden

Location

University Hospital

Lund, 22185, Sweden

Location

Academic Children's Hospital

Uppsala, 75185, Sweden

Location

Hôpital des Enfants

Geneva, 1211, Switzerland

Location

Related 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. doi: 10.1159/000102967. Epub 2007 May 21. No abstract available.

    PMID: 17992017BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, urine

MeSH Terms

Conditions

Brain Damage, Chronic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olaf Dammann

    Medical School Hannover

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2007

First Posted

October 16, 2007

Study Start

October 1, 2007

Study Completion

October 1, 2010

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

IT(2)SE(3)CH(1)AU(1)FR(1)NL(1)DE(3)