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Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in VLBW Infants Using Quantitative NIRS
This study has been completed.
Study NCT00544375   Information provided by University of California, Irvine
First Received: October 12, 2007   Last Updated: October 1, 2008   History of Changes

October 12, 2007
October 1, 2008
June 2002
September 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00544375 on ClinicalTrials.gov Archive Site
 
 
 
Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in VLBW Infants Using Quantitative NIRS
Non-Invasive Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in Very Low Birth Weight Infants Using Quantitative Near-Infrared Spectroscopy

Purpose;

The study quantified functional measures of red blood cell mass and oxygen in neonatal tissues using a non-invasive optical technique: near infrared optical spectroscopy (NIRS). The study will determine the absolute concentrations of deoxygenated and oxygenated hemoglobin and calculate the tissue hemoglobin saturation and total hemoglobin concentration in vivo. NIRS technique use to assessing and defining tissue status in the anemic state and the tissue's response to transfusions, as well as in monitoring hemoglobin and hematocrit without pain or loss of blood.

Hypothesis;

NIRS measurements of hemoglobin and hemoglobin saturation in tissues before and after red-cell transfusions in VLBW infants will determine the true effect of the transfusions, and develop more substantial guidelines regarding indications for transfusion. The accuracy of conventional (invasive) measurements of Hb and Hct could be comparison with results from the NIRS technique and clinical usefulness of the NIRS technique could be evaluated by comparison with trends in conventionally measured values taking fluid status into account.

The red to near-infrared part of the electromagnetic spectrum (600 to 1000 nm) allows photons to penetrate a few centimeters below the surface of the skin. These photons are non-ionizing and do not induce local heating. Quantitative optical spectroscopy in the 600-1000 nm region thus allows safe, non-invasive measurements of the concentrations of blood, water, and lipids in tissues. NIRS spectroscopy has been in use for clinical studies (UCI HS#1995-563 HS#2002-2306). These studies have shown clearly the enormous sensitivity of quantitative NIRS spectroscopy to hemodynamic events in tissues.

Procedure;

NIRS measurements will be conducted on the muscle, on the upper leg,arm or on the back, abdomen and the head. The actual location will depend upon the neonate position and size. A small soft plastic optical fibers probe will be placed to the select study areas and thhe time of the measurement will not exceed 1 hour.

Anticipate risk and benefit;

Near-infrared light does not ionize biological tissue and poses no significant health risk. Since water absorption is low within this spectral range, local heating of the tissue is also minimal. Burns and heat damage to the neonate are highly unlikely.

There are no known direct therapeutic benefits of this procedure.

 
Observational
Case-Only, Prospective
  • Low Birth Weight Infant
  • Anemia
  • Blood Transfusion
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • infants weighing less than 1500 grams at birth
  • infants receiving at least one packed red blood cell transfusion

Exclusion Criteria:

  • neonates who are too unstable as determined by the clinicians for additional human contact
Both
up to 1 Month
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00544375
Feizal Waffarn, M.D, Beckman Laser Institute
RR-01192, RR-CA-09054, NIH-LAMMP
University of California, Irvine
  • Beckman Laser Institute University of California Irvine
  • Department of Pediatrics,University of California Irvine
Principal Investigator: Feizal Waffarn, M.D Beckman Laser Institute University of California Irvine
University of California, Irvine
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP