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Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in VLBW Infants Using Quantitative NIRS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00544375
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : February 10, 2017
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

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.

Condition or disease Intervention/treatment
Infant Development Device: Optical measurement

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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Invasive Measurements of Anemia and Physiologic Tissue Response to Blood Transfusions in Very Low Birth Weight Infants Using Quantitative Near-Infrared Spectroscopy
Study Start Date : June 2002
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Neonatal Tissues
Optical measurement neonatal tissues
Device: Optical measurement
Optical measurement neonatal tissues

Primary Outcome Measures :
  1. Infant tissue's response to transfusions [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00544375

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United States, California
Neonatal Intensive Care Unit, University of California Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
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Principal Investigator: Feizal Waffarn, M.D Beckman Laser Institute University of California Irvine
Study Director: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
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Responsible Party: Beckman Laser Institute and Medical Center, Feizal Waffarn, M.D, University of California, Irvine Identifier: NCT00544375    
Other Study ID Numbers: NIH-LAMMP-2001-2011
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Hematologic Diseases