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

Army Medical University of People's Liberation Army

Status: Withdrawn

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

Treatments: Other: RBC transfusion; Other: no-RBC transfusion

Study type: Observational

Funder types: Other

Identifiers

NCT04921696

NECandRBC

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 minute to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

RBC transfusion

Description:

RBC was transfused to the infants.

Treatment:

Other: RBC transfusion

no-RBC transfusion

Description:

RBC was not transfused to the infants.

Treatment:

Other: no-RBC transfusion