- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01255618
The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?
December 6, 2010 updated by: Zekai Tahir Burak Women's Health Research and Education Hospital
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
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ugur dilmen, proff
- Phone Number: +90 312 506 5270
- Email: ugurdilmen@gmail.com
Study Locations
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Altındag
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Ankara, Altındag, Turkey, 06330
- Recruiting
- Zekai Tahir Maternity Teaching Hospital
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Contact:
- gonca sandal, M.D.
- Phone Number: +90 505 487 10 27
- Email: kocabasgonca@mynet.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
study group, control group
|
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
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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