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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Oxygenation; Peripheric Oxygenation; Polycythaemic Infants
• Intervention / Treatment: Device: INVOS 5100

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Turkey
  • Altındag
    • Ankara, Altındag, Turkey, 06330
      • Recruiting
      • Zekai Tahir Maternity Teaching Hospital
      • Contact: gonca sandal, M.D.; Phone Number: +90 505 487 10 27; Email: kocabasgonca@mynet.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 hours to 2 days (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Preterm infants who admitted to neonatal intensive care unit.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cerebral oxygenation measurement	6 months

Collaborators and Investigators

• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Estimate): December 7, 2010
• Last Update Submitted That Met QC Criteria: December 6, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)