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

NCT01255618 | Unknown DMC

• 1 other identifier: 2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Oxygenation; Peripheric Oxygenation; Polycythaemic Infants

Outcome Measures

Primary Outcomes (1)

• cerebral oxygenation measurement

  6 months

Study Arms (1)

study group, control group

Device: INVOS 5100

Interventions

INVOS 5100 DEVICE

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.

study group, control group

Eligibility Criteria

• Age: 4 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants who admitted to neonatal intensive care unit.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Zekai Tahir Maternity Teaching Hospital

Ankara, Altındag, 06330, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: NONE RETAINED

blood

Central Study Contacts

ugur dilmen, proff

CONTACT

+90 312 506 5270; ugurdilmen@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 7, 2010

Record last verified: 2010-11

Locations

TU (1)