- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264563
"Iatrogenesis Imperfecta"- Extent and Characteristic in NICU in Israel.
June 16, 2011 updated by: Bnai Zion Medical Center
Iatrogenesis is inevitable in the NICUs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In the first 3 months of the study we will document Iatrogenic events in 3 NICUs in Israel without informing the medical and nursing staff.
In the second 3 months of the study we will try to draw the attention of the medical and nursing staff that we are documenting iatogenesis, and we will assess wether this intervention will decrease the events of Iatrogenesis.
Study Type
Observational
Enrollment (Anticipated)
750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haifa, Israel
- Bnai Zion Medical Center
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Haifa ans Ashkelon, Israel, 31048
- Bnai Zion Medical Center, Rambam Medical Center, Barzilay Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Ifants admitted to NICU during the study period
Description
Inclusion Criteria:All infants in NICU -
Exclusion Criteria:None
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Behavioral
The intervention is basically by letting the care givers to be aware that there is active recording of iatrogenesis
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Increasing the level of awareness to Iatrogenesis
Increasing awareness to Iatrogenesis and active daily recordings
Other Names:
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amir Kugelman, Senior Neonatologist
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
December 12, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (Estimate)
December 13, 2005
Study Record Updates
Last Update Posted (Estimate)
June 17, 2011
Last Update Submitted That Met QC Criteria
June 16, 2011
Last Verified
August 1, 2005
More Information
Terms related to this study
Other Study ID Numbers
- 80/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.