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

NCT04921696 | Withdrawn DMC

• 1 other identifier: NECandRBC
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Necrotizing enterocolitis

  Necrotizing enterocolitis was diagnosed within 28 days

  within 28 days

Secondary Outcomes (1)

• death

  within 28 days

Study Arms (2)

RBC transfusion

RBC was transfused to the infants.

Other: RBC transfusion

no-RBC transfusion

RBC was not transfused to the infants.

Other: no-RBC transfusion

Interventions

RBC transfusion OTHER

RBC was transfused to the infants.

RBC transfusion

no-RBC transfusion OTHER

RBC was not transfused to the infants.

no-RBC transfusion

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The level of blood bilirubin of the included neonatal infants reached the cirteria of transfusion therapy. Whether or not the transfusion therapy was dicided according to the parents' decision.

You may qualify if:

• age between 1 min and 28 days
• the level blood bilirubin reached the criteria of transfusion therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Anemia

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 10, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2023

Record last verified: 2022-10

Locations

CN (1)