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

NCT ID: NCT00544375

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2008-09-30

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.

Conditions

Infant Development

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Neonatal Tissues

Optical measurement neonatal tissues

Optical measurement

Intervention Type: DEVICE

Optical measurement neonatal tissues

Interventions

Optical measurement

Optical measurement neonatal tissues

Intervention Type: DEVICE

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Laser Institute University of California Irvine

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Beckman Laser Institute and Medical Center

Feizal Waffarn, M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feizal Waffarn, M.D

Role: PRINCIPAL_INVESTIGATOR

Beckman Laser Institute University of California Irvine

Bruce Tromberg, PhD

Role: STUDY_DIRECTOR

Beckman Laser Institute University of California Irvine

Locations

Neonatal Intensive Care Unit, University of California Irvine

Orange, California, United States

Countries

United States

Other Identifiers

20012011

Identifier Type: -

Identifier Source: org_study_id