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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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital Identifier:
First received: December 6, 2010
Last updated: December 23, 2010
Last verified: December 2010
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

Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • cerebral oxygenation [ Time Frame: 6 months ]

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.


Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primer care clinic

Inclusion Criteria:

.<34 gestation week preterm infants with intracranial haemorrhagia

Exclusion Criteria:

  • sepsis
  • NEC
  • congenital abnormalities
  • hydrocephalus
  • intracranial infections
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01266889

Contact: ugur dilmen, proff +90 312 506 5270

Melek Akar Recruiting
Ankara, Hamamönü, Turkey, 06330
Contact: melek akar, M.D    +90 505 255 05 18   
Principal Investigator: melek akar, M,D         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Responsible Party: Zekai Tahir Burak Maternity and Teaching Hospital Identifier: NCT01266889     History of Changes
Other Study ID Numbers: 3
Study First Received: December 6, 2010
Last Updated: December 23, 2010

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
preterm infant,cerebral oxygenation, intracranial haemorrhagia processed this record on April 26, 2017