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

Status

Unknown

Conditions

Intervention / Treatment

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 Locations

  • Turkey
    • Samanpazarı
      • Ankara, Samanpazarı, Turkey, 06460
        • Recruiting
        • Zekai Tahir Burak Maternity Teaching Hospital
        • Contact:

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
Device: INVOS 5100
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.

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

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

Keywords

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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