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

NCT ID: NCT04921696

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

RBC transfusion

RBC was transfused to the infants.

RBC transfusion

Intervention Type: OTHER

RBC was transfused to the infants.

no-RBC transfusion

RBC was not transfused to the infants.

no-RBC transfusion

Intervention Type: OTHER

RBC was not transfused to the infants.

Interventions

RBC transfusion

RBC was transfused to the infants.

Intervention Type: OTHER

no-RBC transfusion

RBC was not transfused to the infants.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chen Long,MD

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

NECandRBC

Identifier Type: -

Identifier Source: org_study_id