Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion
1 other identifier
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2010
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2010
CompletedFirst Posted
Study publicly available on registry
December 1, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 7, 2010
November 1, 2010
6 months
November 30, 2010
December 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cerebral and peripheric oxygenation measurements in anemic preterm infants.
6 months
Study Arms (1)
gest age, cerebral ,somatic oxygenation measurement
EXPERIMENTALInterventions
duration:six hours
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.
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 Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Zekai Tahir Maternity Teaching Hospital
Ankara, Hamamönü, 06330, Turkey (Türkiye)
Zekai Tahir Maternity Teaching Hospital
Ankara, Hamamönü, 06330, Turkey (Türkiye)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 30, 2010
First Posted
December 1, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
December 7, 2010
Record last verified: 2010-11