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Clinical Trials/NCT00544375
NCT00544375
Completed
Not Applicable

Non-Invasive Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in Very Low Birth Weight Infants Using Quantitative Near-Infrared Spectroscopy

University of California, Irvine1 site in 1 country120 target enrollmentJune 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant Development
Sponsor
University of California, Irvine
Enrollment
120
Locations
1
Primary Endpoint
Infant tissue's response to transfusions
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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 . The study will determine the absolute concentrations of deoxygenated and oxygenated hemoglobin and calculate the tissue hemoglobin saturation and total hemoglobin concentration in viv. Near infrared optical spectroscopy 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.

Detailed Description

Near infrared optical spectroscopy 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. 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. 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.

Registry
clinicaltrials.gov
Start Date
June 2002
End Date
September 2008
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beckman Laser Institute and Medical Center

Feizal Waffarn, M.D

University of California, Irvine

Eligibility Criteria

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

Outcomes

Primary Outcomes

Infant tissue's response to transfusions

Time Frame: 4 weeks

Study Sites (1)

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