Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 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:
NCT01251068
First received: November 30, 2010
Last updated: December 6, 2010
Last verified: November 2010
  Purpose

Near infrared spectroscopy offers the possibility of noninvasive and continuous bedside investigation of cerebral oxygenation in newborn infants. Using this technique we investigated the relationship between changes in cerebral oxygenation and hemodynamics, and changes in some physiological variables during blood transfusion in anaemic preterm infants.


Condition Intervention
Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion
Device: near infrared spectroscopy: invos 5100
Device: INVOS 5100
Device: near infrared spectroscopy device

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • Cerebral and peripheric oxygenation measurements in anemic preterm infants. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gest age, cerebral ,somatic oxygenation measurement Device: near infrared spectroscopy: invos 5100
duration:six hours
Device: INVOS 5100
NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.
Device: near infrared spectroscopy device
NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: <32 gestational age and/or <1500gr.,>30th day preterm infants -

Exclusion Criteria:sepsis,shock,severe intracranial hemorrhage,NEC,abdominal and cranial surgery

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01251068

Contacts
Contact: gonca sandal, MD 05054871028 kocabasgonca@mynet.com

Locations
Turkey
Zekai Tahir Maternity Teaching Hospital Recruiting
Ankara, Hamamönü, Turkey, 06330
Contact: gonca sandal, MD    +905054871028    kocabasgonca@mynet.com   
Principal Investigator: gonca sandal, MD         
Zekai Tahir Maternity Teaching Hospital Recruiting
Ankara, Hamamönü, Turkey, 06330
Contact: UGUR , DILMEN    +903125065270    ugurdilmen@gmail.com   
Principal Investigator: gonca sandal, MD         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital, Neonatal Intensive Care Unit
ClinicalTrials.gov Identifier: NCT01251068     History of Changes
Other Study ID Numbers: 1
Study First Received: November 30, 2010
Last Updated: December 6, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion

ClinicalTrials.gov processed this record on July 31, 2014