search
Back to results

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

Primary Purpose

Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
near infrared spectroscopy: invos 5100
INVOS 5100
near infrared spectroscopy device
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion focused on measuring anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion

Eligibility Criteria

30 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

-

Sites / Locations

  • Zekai Tahir Maternity Teaching HospitalRecruiting
  • Zekai Tahir Maternity Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gest age, cerebral ,somatic oxygenation measurement

Arm Description

Outcomes

Primary Outcome Measures

Cerebral and peripheric oxygenation measurements in anemic preterm infants.

Secondary Outcome Measures

Full Information

First Posted
November 30, 2010
Last Updated
December 6, 2010
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01251068
Brief Title
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion
Official Title
Measurement of Cerebral and Peripheric Tissue Oxygenation in Anemic Preterm Infants Who Underwent Blood Transfusion:A Near Infrared Spectroscopy Study.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemic Preterms, Cerebral Oxygenation,Somatic Oxygenation,Blood Transfusion
Keywords
anemic preterms, cerebral oxygenation,somatic oxygenation, blood transfusion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gest age, cerebral ,somatic oxygenation measurement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
near infrared spectroscopy: invos 5100
Intervention Description
duration:six hours
Intervention Type
Device
Intervention Name(s)
INVOS 5100
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
near infrared spectroscopy device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral and peripheric oxygenation measurements in anemic preterm infants.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility 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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gonca sandal, MD
Phone
05054871028
Email
kocabasgonca@mynet.com
Facility Information:
Facility Name
Zekai Tahir Maternity Teaching Hospital
City
Ankara
State/Province
Hamamönü
ZIP/Postal Code
06330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
gonca sandal, MD
Phone
+905054871028
Email
kocabasgonca@mynet.com
First Name & Middle Initial & Last Name & Degree
gonca sandal, MD
Facility Name
Zekai Tahir Maternity Teaching Hospital
City
Ankara
State/Province
Hamamönü
ZIP/Postal Code
06330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UGUR, DILMEN
Phone
+903125065270
Email
ugurdilmen@gmail.com
First Name & Middle Initial & Last Name & Degree
gonca sandal, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs