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

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Department of Pediatrics,University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00544375
First received: October 12, 2007
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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.


Condition
Low Birth Weight Infant
Anemia
Blood Transfusion

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Enrollment: 120
Study Start Date: June 2002
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544375

Locations
United States, California
Neonatal Intensive Care Unit, University of California Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Department of Pediatrics,University of California Irvine
Investigators
Principal Investigator: Feizal Waffarn, M.D Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00544375     History of Changes
Other Study ID Numbers: RR-01192, RR-CA-09054, NIH-LAMMP
Study First Received: October 12, 2007
Last Updated: October 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
infant

Additional relevant MeSH terms:
Anemia
Birth Weight
Hematologic Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014