Anemia Clinical Trial
Official title:
Association of Red Blood Cell Transfusion, Anemia, and Necrotizing Enterocolitis
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Status | Withdrawn |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 |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Children's Hospital of Chongqing Medical University |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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