RBC Irradiation, Anemia and Gut Injury

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
ELBW Infants without NEC	Near Infrared Spectroscopy	Extremely Low Birth Weight Infants without Necrotizing Enterocolitis being tested with Near Infrared Spectroscopy.
ELBW Infants with Prolonged Irradiation Storage Time	Near Infrared Spectroscopy	Extremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion had prolonged Irradiation Storage Time (IST) being tested with metabolomics profile.
ELBW Infants without Irradiation Storage	Near Infrared Spectroscopy	Extremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion did not have Irradiation Storage being tested with metabolomics profile.
ELBW Infants with NEC	Near Infrared Spectroscopy	Extremely Low Birth Weight Infants with Necrotizing Enterocolitis (NEC defined as "Bell's Stage II or greater) and receiving Red Blood Cell (RBC) Transfusions being tested with Near Infrared Spectroscopy.

Primary Outcome Measures

Name	Time	Method
Changes in Mesenteric Tissue Oxygenation	Week 30 to Week 34 Post Menstrual Age	ELBW infants that reach the window when NEC typically occurs will be further compared as those with vs without anemia. Regional Oxygenation Saturation Levels (rSO2) are measured via the INVOS 5100C Cerebral/Somatic Oximeter by applying an adhesive sensor probe to the patient's periumbilical area for mesenteric monitoring. NIRS will be performed once per week (whether transfused or not) for a 48 hour period starting each Monday (day of routine lab draw to evaluate anemia).

Secondary Outcome Measures

Name	Time	Method

Locations (3): Grady Memorial Hospital
🇺🇸
Atlanta, Georgia, United States
Emory University Hospital Midtown
🇺🇸
Atlanta, Georgia, United States
Northside Hospital - Neonatology
🇺🇸
Atlanta, Georgia, United States

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