NCT04921696

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 1 Minute – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis
• Anemia
• Red Blood Cell (RBC) Transfusion

Interventions

Type	Name	Description
OTHER	RBC transfusion	RBC was transfused to the infants.
OTHER	no-RBC transfusion	RBC was not transfused to the infants.

Timeline

• Start date: 2021-07-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-06-10
• Last updated: 2023-05-01

Locations

1 site across 1 country: China