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

Primary Purpose

HYPERNATREMIA

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
INVOS 5100
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for HYPERNATREMIA focused on measuring CEREBRAL OXYGENATION, HYPERNATREMİA, NEWBORN, NA VALUES

Eligibility Criteria

1 Day - 1 Month (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • gestation week > 37 ve Na >150 mg/dl
  • Dehydration

Exclusion Criteria:

  • Sepsis
  • Intracranial Haemorrhagia
  • Congenital Cardiac Diseases

Sites / Locations

  • Zekai Tahir Burak Maternity Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

cerebral oxygenation

Arm Description

Outcomes

Primary Outcome Measures

CEREBRAL OXYGENATION
NIRS METHODS

Secondary Outcome Measures

NEURODEVELOPMENT
NEURODEVELOPMENT EVALUATION

Full Information

First Posted
February 17, 2011
Last Updated
February 17, 2011
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01299428
Brief Title
Evaluation of the Cerebral Oxygenation With Near Infrared Spectrophotometry (NIRS) at the Hypernatremic Dehydration in Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HYPERNATREMIA
Keywords
CEREBRAL OXYGENATION, HYPERNATREMİA, NEWBORN, NA VALUES

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cerebral oxygenation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
INVOS 5100
Intervention Description
INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.
Primary Outcome Measure Information:
Title
CEREBRAL OXYGENATION
Description
NIRS METHODS
Time Frame
3 MONTHS
Secondary Outcome Measure Information:
Title
NEURODEVELOPMENT
Description
NEURODEVELOPMENT EVALUATION
Time Frame
12-18 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: gestation week > 37 ve Na >150 mg/dl Dehydration Exclusion Criteria: Sepsis Intracranial Haemorrhagia Congenital Cardiac Diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
melek akar, M.D
Phone
+905052550518
Email
melek_akar@yahoo.com.tr
Facility Information:
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
State/Province
Samanpazarı
ZIP/Postal Code
06460
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
melek akar, M.D.
Phone
+905052550518
Email
melek_akar@yahoo.com.tr

12. IPD Sharing Statement

Learn more about this trial

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

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