Neonatal Estimation Of Brain Damage Risk And Identificati... | NCT00544895

Studies
Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

NCT00544895

Sponsor

Hannover Medical School

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Brain Damage, Chronic

Interventions

Not provided

Countries

Austria
France
Germany
Italy
Netherlands
Sweden
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Not provided

Completion Date

Oct 2010Actual

First Submitted Date

Oct 12, 2007

First Submission Date that Met QC Criteria

Oct 15, 2007

First Posted Date

Oct 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Name	Class
European Commission	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Brain white matter damage (WMD, defined by MRI ,US, EEG)		during stay in NICU and until discharge

Secondary Outcomes

Measure	Description	Time Frame
Developmental assessment		at 2 years of age

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Gestational age < 28 weeks

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Preterm newborns with a gestational age < 28wks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olaf Dammann	Medical School Hannover	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Universität Innsbruck		Innsbruck		6020	Austria
Hôpital Robert Debré

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17992017	Background	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D002908	Chronic Disease