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

April 28, 2023 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 4 weeks (Child)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RBC transfusion
RBC was transfused to the infants.
Other: RBC transfusion
RBC was transfused to the infants.
no-RBC transfusion
RBC was not transfused to the infants.
Other: no-RBC transfusion
RBC was not transfused to the infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Necrotizing enterocolitis
Time Frame: within 28 days
Necrotizing enterocolitis was diagnosed within 28 days
within 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: within 28 days
the infant died
within 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

June 6, 2021

First Submitted That Met QC Criteria

June 6, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NECandRBC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anemia

Clinical Trials on RBC transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe