Brain Damage, ChronicNEOBRAINNCT00544895
Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants
An observational study of Brain Damage, Chronic, run by Hannover Medical School at 12 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Damage, Chronic
- How many people
- 600 participants
- Where
- 12 sitesin 7 countries
- Study dates
- Oct 2007to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Preterm newborns with a gestational age < 28wks
Who may be able to join
- Gestational age < 28 weeks
Who cannot join
None listed.
Trial locations and contacts
12 sites in 7 countries.
12 sites in 7 countries
Germany3 sites
Charité, Campus Virchow Klinikum
Berlin, 13353
Universität Duisburg-Essen
Essen, 45122
Hannover Medical School
Hanover, 30625
Sweden3 sites
Perinatal Center
Gothenburg, 41685
University Hospital
Lund, 22185
Academic Children's Hospital
Uppsala, 75185
Italy2 sites
Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.
Milan
Azienda Ospedaliera Universitaria Senese
Siena, 53100
About this study
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)
- Conditions
- Brain Damage, Chronic
- Medical subject headings
- Brain Damage, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain white matter damage (WMD, defined by MRI ,US, EEG)
Measured: during stay in NICU and until discharge
Secondary outcomes (1)
Developmental assessment
Measured: at 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Damage, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Investigators
- Olaf Dammann, Study director, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544895
- Sponsor's protocol ID
- LSHM-CT-2006-036534
- Acronym
- NEOBRAIN
- Status last verified
- Jun 2011
- First submitted
- 12 Oct 2007
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17992017
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants
- ClinicalTrials.gov ID
- NCT00544895
- Acronym / sponsor ID
- NEOBRAIN / LSHM-CT-2006-036534
- Conditions
- Brain Damage, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- Oct 2007
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm newborns with a gestational age < 28wks
Key inclusion criteria (1 listed)
- Gestational age < 28 weeks
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain white matter damage (WMD, defined by MRI ,US, EEG)
Time frame: during stay in NICU and until discharge
1 secondary outcome
Developmental assessment
Time frame: at 2 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
- Background: PubMed 17992017Dammann 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Dammann study director
Medical School Hannover
12 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage, Chronic, run by Hannover Medical School at 12 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Sweden, Italy, Austria, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain white matter damage (WMD, defined by MRI ,US, EEG) (time frame: during stay in NICU and until discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00544895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.