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 because the information has not been verified recently.
Verified November 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: NA
Last verified: November 2010
History: No changes posted
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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

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.


Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Preterm infants who admitted to neonatal intensive care unit.

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.

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Please refer to this study by its identifier: NCT01255618

Contact: ugur dilmen, proff +90 312 506 5270

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

No publications provided

Responsible Party: Zekai Tahir Burak Maternity Teaching Hospital Identifier: NCT01255618     History of Changes
Other Study ID Numbers: 2
Study First Received: December 6, 2010
Last Updated: December 6, 2010
Health Authority: Turkey: Ethics Committee processed this record on November 24, 2015