Brain InjuryBrainZNCT00516334
Study of Bedside EEG to Evaluate Brain Injury in Premature Newborns
An observational study of Brain Injury and Seizures, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants. Read more about this study
- Who is it for?
- Ages 1 day to 36 months
- Conditions the study is for
- Brain Injury, Seizures, Cerebral Palsy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2013
- 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 1 day to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants <29 weeks gestational age
Who may be able to join
- Infants inborn below 28 weeks gestation
Who cannot join
- At birth, deemed not likely to survive 7 days or more
- Major intracranial congenital anomaly
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
Read the detailed description
Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.
- Conditions
- Brain Injury, Seizures, Cerebral Palsy
- Keywords
- brain, electroencephalography, premature infant, neurodevelopment
- Medical subject headings
- Brain Injuries, Seizures, Cerebral Palsy, Premature Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startMay 2006
- Primary completionMay 2009
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda J. Van Marter, M.D., M.P.H., Brigham and Women's Hospital
- Investigators
- Linda J Van Marter, MD, MPH, Principal investigator, Brigham and Women's HospitalDeirdre O'Reilly, MD, MPH, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516334
- Sponsor's protocol ID
- 2003-P-000088
- Acronym
- BrainZ
- Status last verified
- Jul 2012
- First submitted
- 13 Aug 2007
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Electrophysiological Studies of the Premature Newborn Infant Brain: Understanding Brain Injury
- ClinicalTrials.gov ID
- NCT00516334
- Acronym / sponsor ID
- BrainZ / 2003-P-000088
- Conditions
- Brain Injury, Seizures, Cerebral Palsy
- Keywords
- brain, electroencephalography, premature infant, neurodevelopment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2013 (estimated)
- First posted
- 15 Aug 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.
This study is evaluating whether a bedside brainwave monitor can be used to detect early brain injury in premature infants.
Detailed description
Patient enrollment and electroencephalographic (EEG) and clinical data collection stopped May 2009. Data analysis is ongoing, and results have been described (O'Reilly D, Navakatikyan MA, Filip M, Greene D, Van Marter LJ. Peak to Peak Amplitude in Neonatal Brain Monitoring of Premature Infants. Clin Neurophysiol 2012 May 16), via publication in a peer-reviewed journal. Another manuscript has been completed and is undergoing revision for resubmission. We anticipate several additional articles will be completed from the data collected during this study. There is no relationship between industry and no current funding for this study. We maintain institutional review board approval due to ongoing data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants <29 weeks gestational age
Key inclusion criteria (1 listed)
- Infants inborn below 28 weeks gestation
Key exclusion criteria (2 listed)
- At birth, deemed not likely to survive 7 days or more
- Major intracranial congenital anomaly
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
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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.
Linda J Van Marter, MD, MPH principal investigator
Brigham and Women's Hospital
Deirdre O'Reilly, MD, MPH study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injury and Seizures, run by Brigham and Women's Hospital at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 27 Jul 2012.