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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00396773
Other study ID # Elactrobrainwaves-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase Phase 0
First received November 6, 2006
Last updated November 8, 2006
Start date February 2007
Est. completion date January 2008

Study information

Verified date November 2006
Source Hadassah Medical Organization
Contact David Mankuta, M.D
Phone 97225791070
Email mankuta@yahoo.com
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

Electrocoagulation effect of neonatal brain waves after cesarean section


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 30 Days
Eligibility Inclusion Criteria:

- term normal newborn after normal pregnancy after elective cesarean section

Exclusion Criteria:

- any fetal or neonatal disease or condition that may affect brain waves

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Contact Arik Tzukert,DMD Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Rosén I. The physiological basis for continuous electroencephalogram monitoring in the neonate. Clin Perinatol. 2006 Sep;33(3):593-611, v. Review. — View Citation

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