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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04921696
• Other study ID #: NECandRBC
• Status: Withdrawn
• Start date: July 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Other:
• RBC transfusion
RBC was transfused to the infants.
• no-RBC transfusion
RBC was not transfused to the infants.

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Necrotizing enterocolitis	Necrotizing enterocolitis was diagnosed within 28 days	within 28 days
Secondary	death	the infant died	within 28 days