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The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?

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 November 2010 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255618
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zekai Tahir Burak Women's Health Research and Education Hospital
  Purpose
Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and hemodynamics, and changes in newborn period.The aim of the present study is to investigate cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial exchange transfusion.

Condition Intervention
Cerebral Oxygenation Peripheric Oxygenation Polycythaemic Infants Device: INVOS 5100

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

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

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

Biospecimen Retention:   None Retained
blood

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
study group, control group Device: INVOS 5100
Near-infrared range and has been used in newborn infants since 1985. Fibre-optic bundles or optodes are placed either on opposite sides of the tissue being interrogated (usually a limb or the head of a young baby) to measure transmitted light, or close together to measure reflected light. Light enters through one optode and a fraction of the photons is captured by a second optode and conveyed to the measuring device. NIRS uses a frequency band between 650 nm and 1000 nm and relies on three important phenomena: (1) human tissue is relatively transparent to light in the near-infrared region of the spectrum; (2) pigmented compounds known as chromophores absorb light as it passes through biological tissue; and (3) human tissues contain substances whose absorption spectra at near-infrared wavelengths are well defined and depend on their oxygenation status.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Preterm infants who admitted to neonatal intensive care unit.
Criteria

Inclusion Criteria:

term (≥37wk) infants whom determined ≥ 65% haematocrit(Hct) levels

Exclusion Criteria:

Infants with severe congenital malformation, sepsis, intracranial hemorrhage, birth asphyxia were excluded from the study.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01255618


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

Locations
Turkey
Zekai Tahir Maternity Teaching Hospital Recruiting
Ankara, Altındag, Turkey, 06330
Contact: gonca sandal, M.D.    +90 505 487 10 27    kocabasgonca@mynet.com   
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

Responsible Party: Zekai Tahir Burak Maternity Teaching Hospital
ClinicalTrials.gov Identifier: NCT01255618     History of Changes
Other Study ID Numbers: 2
First Submitted: December 6, 2010
First Posted: December 7, 2010
Last Update Posted: December 7, 2010
Last Verified: November 2010