- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299428
Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn
February 17, 2011 updated by: Zekai Tahir Burak Women's Health Research and Education Hospital
The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: melek akar, M.D
- Phone Number: +905052550518
- Email: melek_akar@yahoo.com.tr
Study Locations
-
-
Samanpazarı
-
Ankara, Samanpazarı, Turkey, 06460
- Recruiting
- Zekai Tahir Burak Maternity Teaching Hospital
-
Contact:
- melek akar, M.D.
- Phone Number: +905052550518
- Email: melek_akar@yahoo.com.tr
-
-
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
1 day to 1 month (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- gestation week > 37 ve Na >150 mg/dl
- Dehydration
Exclusion Criteria:
- Sepsis
- Intracranial Haemorrhagia
- Congenital Cardiac Diseases
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
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: cerebral oxygenation
|
INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CEREBRAL OXYGENATION
Time Frame: 3 MONTHS
|
NIRS METHODS
|
3 MONTHS
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NEURODEVELOPMENT
Time Frame: 12-18 MONTHS
|
NEURODEVELOPMENT EVALUATION
|
12-18 MONTHS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2011
Primary Completion (ANTICIPATED)
May 1, 2011
Study Completion (ANTICIPATED)
August 1, 2011
Study Registration Dates
First Submitted
February 17, 2011
First Submitted That Met QC Criteria
February 17, 2011
First Posted (ESTIMATE)
February 18, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 18, 2011
Last Update Submitted That Met QC Criteria
February 17, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5
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.
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