RBC Irradiation, Anemia and Gut Injury

Last updated: April 19, 2021
Sponsor: Emory University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anemia

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT02741648
IRB00083691
2P01HL086773
1R01HL138714
  • Ages < 5
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Birth weight ≤1250 grams
  • Postnatal age within 7 days of birth

Exclusion

Exclusion Criteria:

  • Infant not expected to live beyond 7 days of life based on assessment of treatingneonatologist
  • Severe congenital abnormality expected to affect life expectancy
  • RBC or platelet transfusion at an outside institution occurring prior to screening
  • Maternal refusal to participate

Study Design

Total Participants: 220
Study Start date:
July 01, 2016
Estimated Completion Date:
April 30, 2022

Study Description

Anemia and digestive tract complications are common problems in Extremely Low Birth Weight infants. Anemia is a condition in which the body does not have enough red blood cells (RBC). RBCs are important because they contain hemoglobin, the substance that carries oxygen throughout the body. Transfusions of RBCs in these infants is frequently required to correct the anemia. Oxygen levels in the digestive tract will be measured before, during and after each blood transfusion using a tissue oxygen monitor called Near Infrared Spectroscopy (NIRS). By using this technology, better understanding can be obtained of intestinal blood flow patterns.

In addition, ELBW infants are more likely to have immature digestive systems and are at risk for digestive tract problems such as necrotizing enterocolitis (NEC). NEC is a disease characterized by infection and decreased blood flow to the intestines. NEC is a major cause of devastating illness and death in this vulnerable preterm population. Leftover blood samples, urine, stool, and breast milk samples will be collected, frozen, and stored. In the event a baby develops a digestive tract complication they will be studied in a laboratory to identify markers that indicate a healthy digestive tract versus illness.

Connect with a study center

  • Emory University Hospital Midtown

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Northside Hospital - Neonatology

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

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