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ACTIVE NOT RECRUITING
NCT02741648

RBC Irradiation, Anemia and Gut Injury

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

The purpose of this trial is to study the effect that anemia and red blood cell (RBC) transfusions have on oxygen levels in the digestive tracts of extremely low birth weight (ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that may lead to a better understanding of what makes an ELBW infant at risk for digestive tract problems such as necrotizing enterocolitis.

Official title: Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants Weighing ≤ 1250 Grams

Key Details

Gender

All

Age Range

1 Day - 5 Days

Study Type

OBSERVATIONAL

Enrollment

324

Start Date

2016-07

Completion Date

2026-02-28

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DEVICE

Near Infrared Spectroscopy

INVOS 5100C Cerebral/Somatic Oximeter is an FDA-approved device used to measure renal and mesenteric tissue oxygenation, as defined by regional oxygenation saturation levels (rSO2). Two probe site monitoring will be used to evaluate differential tissue bed oxygenation. Adhesive sensor probes are applied to the periumbilical area for mesenteric monitoring and to the flank area for renal monitoring.

OTHER

Non-invasive Image-based Anemia Assessment

A trained research associate will take 2 images (one with the camera flash on and one with the camera flash off) of the patient's fingernail beds, toe nail beds, palm of the hand and sole of the foot. Images will be taken within 24 hours, preceding, or following, each complete blood count (CBC) collection on each consented patient. The anemia diagnosing algorithm will then be run on the images.

Locations (3)

Grady Memorial Hospital

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Northside Hospital - Neonatology

Atlanta, Georgia, United States