Clinical trial NCT02741648: RBC Irradiation, Anemia and Gut Injury
Official title: Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants Weighing ≤ 1250 Grams
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Necrotizing Enterocolitis
Keywords: Red Blood Cell Transfusion
Digestive tract problems
Extremely Low Birth Weight
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-04-18
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extremely low birth weight newborn infants born at Emory University Hospital Midtown, Grady Health System, and Northside Hospital Neonatology. Infants will be followed at Children's Healthcare of Atlanta.

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.

Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Changes in Mesenteric Tissue Oxygenation
timeFrame: 60 Minutes prior to transfusion to 48 hours after transfusion
measure: Changes in Mesenteric Tissue Oxygenation
timeFrame: Week 30 to Week 34 Post Menstrual Age
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital - Neonatology
state: Georgia
Study officials:
affiliation: Emory University
name: Cassandra Josephson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marin T, Patel RM, Roback JD, Stowell SR, Guo Y, Easley K, Warnock M, Skvarich J, Josephson CD. Does red blood cell irradiation and/or anemia trigger intestinal injury in premature infants with birth weight </= 1250 g? An observational birth cohort study. BMC Pediatr. 2018 Aug 11;18(1):270. doi: 10.1186/s12887-018-1241-5.