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

Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion Clinical Trial

Official title:

Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01251068
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2010
• Last updated: December 6, 2010
• Start date: December 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2010
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: gonca sandal, MD
• Phone: 05054871028
• Email: kocabasgonca[@]mynet.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion
• Premature Birth

Intervention

Device:
• near infrared spectroscopy: invos 5100
duration:six hours
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Maternity Teaching Hospital	Ankara	Hamamönü
Turkey	Zekai Tahir Maternity Teaching Hospital	Ankara	Hamamönü

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral and peripheric oxygenation measurements in anemic preterm infants.		6 months	No