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RBC Irradiation, Anemia and Gut Injury

NCT02741648 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 324

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Anemia
  • Necrotizing Enterocolitis

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Ravi Patel, MD, MSc · Emory University

Eligibility

Min Age
1 Day
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02741648 on ClinicalTrials.gov