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 Women's Health Research and Education Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Zekai Tahir Burak Women's Health Research and Education 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 Women's Health Research and Education 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Women's Health Research and Education 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 Women's Health Research and Education Hospital:


CEREBRAL OXYGENATION HYPERNATREMİA NEWBORN NA VALUES

Additional relevant MeSH terms:


Hypernatremia Metabolic Diseases Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on March 01, 2015

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