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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Zekai Tahir Burak Maternity and Teaching Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01299428
First received: February 17, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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


Condition Intervention
HYPERNATREMIA
 Device: INVOS 5100

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:

MedlinePlus related topics: Dehydration
U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • CEREBRAL OXYGENATION [ Time Frame: 3 MONTHS ] [ Designated as safety issue: Yes ]
    NIRS METHODS


Secondary Outcome Measures:
  • NEURODEVELOPMENT [ Time Frame: 12-18 MONTHS ] [ Designated as safety issue: Yes ]
    NEURODEVELOPMENT EVALUATION


Estimated Enrollment: 2
Study Start Date: February 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cerebral oxygenation Device: INVOS 5100
INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Maternity and Teaching Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity Teaching Hospital
ClinicalTrials.gov Identifier: NCT01299428     History of Changes
Other Study ID Numbers: 5
Study First Received: February 17, 2011
Last Updated: February 17, 2011
Health Authority: TURKEY:INSTITUTIONAL REVIEW BOARD

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
CEREBRAL OXYGENATION
HYPERNATREMİA
NEWBORN
NA VALUES

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

ClinicalTrials.gov processed this record on May 22, 2013