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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04921696
Enrollment
0
Registered
2021-06-10
Start date
2021-07-01
Completion date
2026-12-31
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

necrotizing enterocolitis, anemia, red blood cell (RBC) transfusion

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.

Interventions

RBC was transfused to the infants.

OTHERno-RBC transfusion

RBC was not transfused to the infants.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Necrotizing enterocolitiswithin 28 daysNecrotizing enterocolitis was diagnosed within 28 days

Secondary

MeasureTime frameDescription
deathwithin 28 daysthe infant died

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026