Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis

Study Overview
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Brief Summary
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Necrotizing enterocolitis (NEC) is a leading cause of mortality among preterm infants.The pathogenesis of NEC remains unclear with conflicting data regarding the role of red blood cell (RBC) transfusion and anemia. A meta-analysis of retrospective studies demonstrated an association between exposure to RBC transfusion and NEC(adjusted odds ratio, 2.0 [95% confidence interval, 1.6-2.5]). However, recent observational studies have found no association between RBC transfusion and NEC or have found RBC transfusion to be protective.

Detailed Description
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Improving understanding of the role of RBC transfusion and anemia in the development of NEC is important. Several studies characterizing the associations between transfusion, anemia, and NEC were potentially limited by small sample size, study design. As such, researchers have underscored the need for prospective study in which each RBC exposure, episode of anemia, and outcome of NEC can be systematically and consistently evaluated. This prospective study examined whether RBC transfusion and anemia were associated with the rate of NEC. The primary objective was to test whether NEC was increased in infants receiving RBC transfusion compared with non transfused infants. Further, exposure to severe neonatal anemia was examined as an independent risk factor for NEC.

Official Title
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Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis

Conditions
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Necrotizing Enterocolitis, Anemia, Red Blood Cell (RBC) Transfusion

Intervention / Treatment
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* Other: RBC transfusion
* Other: no-RBC transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 1 min and 28 days the level blood bilirubin reached the criteria of transfusion therapy Exclusion Criteria: congenital abnormalities receipt of transfusion before enrollment parents' decision not to participate infant not expected to survive beyond 7 days of life based on the assessment by the treating neonatologist

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RBC transfusion<br>RBC was transfused to the infants. | Other: RBC transfusion<br>* RBC was transfused to the infants.<br>|
| no-RBC transfusion<br>RBC was not transfused to the infants. | Other: no-RBC transfusion<br>* RBC was not transfused to the infants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Necrotizing enterocolitis | Necrotizing enterocolitis was diagnosed within 28 days | within 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | the infant died | within 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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necrotizing enterocolitis, anemia, red blood cell (RBC) transfusion