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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 Maternity and Teaching Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01251068
First received: November 30, 2010
Last updated: December 6, 2010
Last verified: November 2010
History of Changes

November 30, 2010
December 6, 2010
December 2010
June 2011   (final data collection date for primary outcome measure)
Cerebral and peripheric oxygenation measurements in anemic preterm infants. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01251068 on ClinicalTrials.gov Archive Site
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Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion
  • 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.
Experimental: gest age, cerebral ,somatic oxygenation measurement
Interventions:
  • Device: near infrared spectroscopy: invos 5100
  • Device: INVOS 5100
  • Device: near infrared spectroscopy device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2011
June 2011   (final data collection date for primary outcome measure)

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

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

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Both
Not Provided
No
Contact: gonca sandal, MD 05054871028 kocabasgonca@mynet.com
Turkey
 
NCT01251068
1
Yes
Zekai Tahir Burak Maternity and Teaching Hospital, Neonatal Intensive Care Unit
Zekai Tahir Burak Maternity and Teaching Hospital
Not Provided
Not Provided
Zekai Tahir Burak Maternity and Teaching Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP