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NCT01299428 Clinical Trial

Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn

HYPERNATREMIA Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01299428
Other study ID # 5
Secondary ID
Status Recruiting
Phase N/A
First received February 17, 2011
Last updated February 17, 2011
Start date February 2011
Est. completion date August 2011

Study information
Verified date February 2011
Source Zekai Tahir Burak Women's Health Research and Education Hospital
Contact melek akar, M.D
Phone +905052550518
Email melek_akar@yahoo.com.tr
Is FDA regulated No
Health authority TURKEY:INSTITUTIONAL REVIEW BOARD
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate cerebral oxygenation with Near infrared spectrophotometry (NIRS) at the hypernatremic dehydration in newborns.

Recruitment information / eligibility
Status Recruiting
Enrollment 2
Est. completion date August 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Month
Eligibility Inclusion Criteria:

- gestation week > 37 ve Na >150 mg/dl

- Dehydration

Exclusion Criteria:

- Sepsis

- Intracranial Haemorrhagia

- Congenital Cardiac Diseases

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Device:
• INVOS 5100
INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.

Locations
Country Name City State
Turkey Zekai Tahir Burak Maternity Teaching Hospital Ankara Samanpazari

Sponsors (1)
Lead Sponsor Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary CEREBRAL OXYGENATION NIRS METHODS 3 MONTHS Yes
Secondary NEURODEVELOPMENT NEURODEVELOPMENT EVALUATION 12-18 MONTHS Yes
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