Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Locations
- 1
- Primary Endpoint
- Necrotizing enterocolitis
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Chen Long,MD
director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Necrotizing enterocolitis
Time Frame: within 28 days
Necrotizing enterocolitis was diagnosed within 28 days
Secondary Outcomes
- death(within 28 days)