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

Withdrawn

• Conditions: Red Blood Cell (RBC) Transfusion; Anemia; Necrotizing Enterocolitis
• Interventions: Other: RBC transfusion; Other: no-RBC transfusion

• Registration Number: NCT04921696
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Timeline

• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-06
• Study First Posted: 2021-06-10
• Study Start: 2021-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RBC transfusion	RBC transfusion	RBC was transfused to the infants.
no-RBC transfusion	no-RBC transfusion	RBC was not transfused to the infants.

Primary Outcome Measures

Name	Time	Method
Necrotizing enterocolitis	within 28 days	Necrotizing enterocolitis was diagnosed within 28 days

Secondary Outcome Measures

Name	Time	Method
death	within 28 days	the infant died

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China