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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04921696
Other study ID # NECandRBC
Secondary ID
Status Withdrawn
Phase
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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