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

Cerebral Oxygenation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01255618
• Other study ID #: 2
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2010
• Last updated: December 6, 2010
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: November 2010
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: ugur dilmen, proff
• Phone: +90 312 506 5270
• Email: ugurdilmen[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Oxygenation
• Peripheric Oxygenation
• Polycythaemic Infants

Intervention

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.

Locations

Country	Name	City	State
Turkey	Zekai Tahir Maternity Teaching Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebral oxygenation measurement		6 months	No