- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00544375
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
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Neonatal Intensive Care Unit, University of California Irvine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neonatal Tissues
Optical measurement neonatal tissues
|
Optical measurement neonatal tissues
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infant tissue's response to transfusions
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Bruce Tromberg, PhD, Beckman Laser Institute University of California Irvine
- Principal Investigator: Feizal Waffarn, M.D, Beckman Laser Institute University of California Irvine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20012011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infant Development
-
Société des Produits Nestlé (SPN)RecruitingInfant Development | Growth and Development | Infant Health | Infant Formula | Infant Nutritional Physiological PhenomenaSaudi Arabia
-
University of ArizonaMead Johnson NutritionRecruiting
-
Hugo W. Moser Research Institute at Kennedy Krieger...Johns Hopkins UniversityNot yet recruitingChild Development | Developmental Delay | Infant Development | Language Development
-
Aussie Bubs, Inc.RecruitingInfant DevelopmentUnited States
-
Washington University School of MedicineUniversity of MinnesotaNot yet recruiting
-
Tokat Gaziosmanpasa UniversityRecruiting
-
University of Colorado, DenverRecruiting
-
Children's Hospital Los AngelesWuqu' Kawoq, Maya Health AllianceActive, not recruitingInfant DevelopmentGuatemala
-
ByHeartEnrolling by invitationInfant DevelopmentUnited States
-
Rontis Hellas SANational and Kapodistrian University of Athens; National Hellenic Research...Completed
Clinical Trials on Optical measurement
-
Tomey CorporationRecruitingCataract | Pseudophakia | Aphakic EyeUnited States
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompleted
-
Mahidol UniversityCompleted
-
Akdeniz UniversityTerminated
-
G. d'Annunzio UniversityUnknownNormal Foveal ThicknessItaly
-
PulseOn OyTAYS Sydänkeskus Oy; Atostek OyCompleted
-
Kahramanmaras Sutcu Imam UniversityCompletedEye Manifestations | Tobacco; Use, Harmful | Tobacco Chewing ToxicityTurkey
-
Medical University of ViennaWithdrawn
-
Seoul National University HospitalUnknownCoronary Artery DiseaseKorea, Republic of
-
ASST Fatebenefratelli SaccoCompletedPneumoperitoneum | Intracranial Hypertension | Brain Edema | Surgery, LaparoscopicItaly