EpilepsyNCT00396773
Neonatal Brain Waves After Electrocoagulation
An observational study of Epilepsy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Electrocoagulation effect of neonatal brain waves after cesarean section Read more about this study
- Who is it for?
- Ages 1 minute to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2007to Jan 2008
- 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 minute to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- term normal newborn after normal pregnancy after elective cesarean section
Who cannot join
- any fetal or neonatal disease or condition that may affect brain waves
Trial locations and contacts
1 site in 1 country.
iSRAEL Matot contact
Israel1 site
Contact Arik Tzukert,DMD
Jerusalem
Arik Tzukert, DMD, 0097226776095, arik@Hadassah.org
Hadas Lmberg, PhD, 0097226777572, lhadas@hdassah.org.il
About this study
Electrocoagulation effect of neonatal brain waves after cesarean section
Read the detailed description
Electrocoagulation is used for bleeding control on usual basis in cesarean sections and other surgical procedures .
We are planning to test the effect of electrocoagulation unipolar on neonatal brain waves compared with neonates that were exposed to bipolar electrocoagulation .Bipolar electrocoagulation should have les of an effect because of it coagulates in a close ,closed electrical cycle .
- Conditions
- Epilepsy
- Keywords
- electrocoagulation,pregnancy,brian waves
- Medical subject headings
- Epilepsy, Hyperthermia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startFeb 2007
- Study completionJan 2008 (estimated)
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 EpilepsyStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- David Mankuta, Principal investigator, Hadassah University Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396773
- Sponsor's protocol ID
- Elactrobrainwaves-HMO-CTIL
- Status last verified
- Nov 2006
- First submitted
- 6 Nov 2006
- Last updated
- 10 Nov 2006
- Results posted
- No
Publications
Rosen I. The physiological basis for continuous electroencephalogram monitoring in the neonate. Clin Perinatol. 2006 Sep;33(3):593-611, v. doi: 10.1016/j.clp.2006.06.013.
PubMed 16950313
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Brain Waves After Electrocoagulation
- ClinicalTrials.gov ID
- NCT00396773
- Acronym / sponsor ID
- Elactrobrainwaves-HMO-CTIL
- Conditions
- Epilepsy
- Keywords
- electrocoagulation,pregnancy,brian waves
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Jan 2008 (estimated)
- First posted
- 7 Nov 2006 (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.
Electrocoagulation effect of neonatal brain waves after cesarean section
Detailed description
Electrocoagulation is used for bleeding control on usual basis in cesarean sections and other surgical procedures .
We are planning to test the effect of electrocoagulation unipolar on neonatal brain waves compared with neonates that were exposed to bipolar electrocoagulation .Bipolar electrocoagulation should have les of an effect because of it coagulates in a close ,closed electrical cycle .
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- term normal newborn after normal pregnancy after elective cesarean section
Key exclusion criteria (1 listed)
- any fetal or neonatal disease or condition that may affect brain waves
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 10 Nov 2006.
- Background: PubMed 16950313Rosen I. The physiological basis for continuous electroencephalogram monitoring in the neonate. Clin Perinatol. 2006 Sep;33(3):593-611, v. doi: 10.1016/j.clp.2006.06.013.
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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.
iSRAEL Matot contact
David Mankuta principal investigator
Hadassah University Medical Organization
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 Epilepsy, run by Hadassah Medical Organization at 1 site in Israel.
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 1 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 10 Nov 2006. 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 Israel. 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?
Contact David Mankuta, M.D (97225791070, mankuta@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396773, 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 10 Nov 2006.