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

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ClinicalTrials.gov Identifier: NCT01299428
Recruitment Status : Unknown
Verified February 2011 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
First Posted : February 18, 2011
Last Update Posted : February 18, 2011
Sponsor:
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital

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

Condition or disease Intervention/treatment Phase
HYPERNATREMIA Device: INVOS 5100 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : February 2011
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: cerebral oxygenation Device: INVOS 5100
INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.


Outcome Measures
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Primary Outcome Measures :
  1. CEREBRAL OXYGENATION [ Time Frame: 3 MONTHS ]
    NIRS METHODS


Secondary Outcome Measures :
  1. NEURODEVELOPMENT [ Time Frame: 12-18 MONTHS ]
    NEURODEVELOPMENT EVALUATION


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Sepsis
  • Intracranial Haemorrhagia
  • Congenital Cardiac Diseases
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299428


Contacts
Contact: melek akar, M.D +905052550518 melek_akar@yahoo.com.tr

Locations
Turkey
Zekai Tahir Burak Maternity Teaching Hospital Recruiting
Ankara, Samanpazarı, Turkey, 06460
Contact: melek akar, M.D.    +905052550518    melek_akar@yahoo.com.tr   
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Zekai Tahir Burak Maternity Teaching Hospital
ClinicalTrials.gov Identifier: NCT01299428     History of Changes
Other Study ID Numbers: 5
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
CEREBRAL OXYGENATION
HYPERNATREMİA
NEWBORN
NA VALUES

Additional relevant MeSH terms:
Hypernatremia
Water-Electrolyte Imbalance
Metabolic Diseases