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Measurement of Cerebral Oxygenation Using NIRS Method in the Preterm Infants With Intracranial Haemorrhagia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 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:
NCT01266889
First received: December 6, 2010
Last updated: December 23, 2010
Last verified: December 2010
History of Changes
  Purpose

The aim of the study was investigated the cerebral tissue oxygenation index (c-TOI) measured by near infrared spectroscopy (NIRS)in the preterm infants with intracranial haemorrhagia.


Condition Intervention
Cerebral Oxygenation, Intracranial Haemorrhagia
 Device: device:INVOS 5100

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • cerebral oxygenation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
study group, control group Device: device:INVOS 5100
Continuous wave NIRS is a method for measurement of cerebral oxygenation and haemodynamics. This method is non-invasive, continuous, and can also be used as bedside monitoring. With continuous wave NIRS only changes in concentration of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) can be measured, not the absolute level of these parameters. It has been shown that changes in concentration of HbD (O2Hb - HHb) reflect changes in CBF. So, continuous monitoring of changes in concentration of HbD can be used as an indicator of changes in CBF, but changes in CBV will also influence the HbD signal, as will changes in arterial O2 saturation (saO2) and changes in cerebral metabolic rate for oxygen.

  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primer care clinic

Criteria

Inclusion Criteria:

.<34 gestation week preterm infants with intracranial haemorrhagia

Exclusion Criteria:

  • sepsis
  • NEC
  • congenital abnormalities
  • hydrocephalus
  • intracranial infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266889

Contacts
Contact: ugur dilmen, proff +90 312 506 5270 ugurdilmen@gmail.com

Locations
Turkey
Melek Akar Recruiting
Ankara, Hamamönü, Turkey, 06330
Contact: melek akar, M.D     +90 505 255 05 18     melek_akar@yahoo.com.tr    
Principal Investigator: melek akar, M,D            
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
  More Information

No publications provided

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01266889     History of Changes
Other Study ID Numbers: 3
Study First Received: December 6, 2010
Last Updated: December 23, 2010
Health Authority: Turkey: Ethics Committee

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
preterm infant,cerebral oxygenation, intracranial haemorrhagia

ClinicalTrials.gov processed this record on May 22, 2013