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

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT04921696

Collaborator

Children's Hospital of Chongqing Medical University (Other)

1,000

Enrollment

Location

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Necrotizing Enterocolitis Anemia Red Blood Cell (RBC) Transfusion	Other: RBC transfusion Other: no-RBC transfusion

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
RBC transfusion RBC was transfused to the infants.	Other: RBC transfusion RBC was transfused to the infants.
no-RBC transfusion RBC was not transfused to the infants.	Other: no-RBC transfusion RBC was not transfused to the infants.

Arm

Intervention/Treatment

RBC transfusion

RBC was transfused to the infants.

Other: RBC transfusion

RBC was transfused to the infants.

no-RBC transfusion

RBC was not transfused to the infants.

Other: no-RBC transfusion

RBC was not transfused to the infants.

Outcome Measures

Primary Outcome Measures

Necrotizing enterocolitis [within 28 days]
Necrotizing enterocolitis was diagnosed within 28 days

Secondary Outcome Measures

death [within 28 days]
the infant died

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 28 Days

Sexes Eligible for Study:

All

Accepts 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