Evidence map›Paper›PMID 38700862›Full record

Trial reportJAMA network open2024

Timing of Red Blood Cell Transfusions and Occurrence of Necrotizing Enterocolitis: A Secondary Analysis of a Randomized Clinical Trial.

Ariel A Salas, Elizabeth Gunn, Waldemar A Carlo, Edward F Bell, Abhik Das, Cassandra D Josephson, Ravi M Patel, Sylvia Tan, Haresh Kirpalani, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in JAMA network open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01702805 (Transfusion of Prematures), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01702805 nacompletednot on this map

Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?

TypeinterventionalSponsorNICHD Neonatal Research NetworkRan2012 to 2025Enrolled1,824ConditionsInfant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD)ArmsLiberal Cell Transfusion, Restricted red cell transfusion
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. [Regional mesenteric oxygen saturation during blood transfusion in premature neonates].Revista medica del Instituto Mexicano del Seguro Social · 2025
    Observational
  7. Article
  8. Article
  9. Review
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Ariel A SalasDepartment of Pediatrics, University of Alabama at Birmingham.
Elizabeth GunnDepartment of Pediatrics, University of Alabama at Birmingham.
Waldemar A CarloDepartment of Pediatrics, University of Alabama at Birmingham.
Edward F BellDepartment of Pediatrics, University of Iowa, Iowa City.
Abhik DasStatistical and Environmental Sciences Unit, RTI International, Washington, DC.
Cassandra D JosephsonCancer and Blood Disorders Institute and Blood Bank/Transfusion Medicine, Johns Hopkins All Children's Hospital, St Petersburg, Florida.
Ravi M PatelDepartment of Pediatrics, Emory University, Atlanta, Georgia.
Sylvia TanStatistical and Environmental Sciences Unit, RTI International, Washington, DC.
Haresh KirpalaniDepartment of Pediatrics, University of Pennsylvania, Philadelphia.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network

Funding

Neonatal Research Network Data Coordinating Center (DCC) 2023-2028U24HD095254 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI Abhik Das · 2018 to 2026
$70.2M
Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Data Ctr for the Cooperative Neonatal Research NetworkU01HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 1998 to 2007
$21.8M
The University of Rochester's Clinical and Translational Science InstituteUL1TR000042 · NCATS · UNIVERSITY OF ROCHESTER · PI BENNETT, NANCY M, KIEBURTZ, KARL D. · 2012 to 2015
$14.4M
University of Iowa Clinical and Translational Science ProgramUL1TR000442 · NCATS · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2012 to 2013
$10.0M
Cincinnati Center for Clinical and Translational Sciences and TrainingUL1TR000077 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E., TSEVAT, JOEL · 2012 to 2014
$9.9M
University of New Mexico Clinical and Translational Science CenterUL1TR000041 · NCATS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI LARSON, RICHARD S · 2012 to 2014
$9.8M
Transfusion-Associated Brain Improvement (TABI) Trial: Data Coordinating CenterU01HL112748 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2012 to 2016
$7.4M
Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1UL1TR000093 · NCATS · STANFORD UNIVERSITY · PI GREENBERG, HARRY BERNARD · 2012 to 2013
$6.5M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027880 · NICHD · STANFORD UNIVERSITY · PI VAN MEURS, KRISA PAGE · 1991 to 2015
$6.1M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021373 · NICHD · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI KENNEDY, KATHLEEN A · 1991 to 2015
$6.1M
NCATS NIH HHS UL1 TR000006NCATS NIH HHS UL1 TR000041NCATS NIH HHS UL1 TR000042NCATS NIH HHS UL1 TR000077NCATS NIH HHS UL1 TR000093NCATS NIH HHS UL1 TR000105NCATS NIH HHS UL1 TR000442NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR001117NHLBI NIH HHS U01 HL112748NHLBI NIH HHS U01 HL112776NICHD NIH HHS K23 HD102554NICHD NIH HHS U01 HD036790NICHD NIH HHS U10 HD021373NICHD NIH HHS U10 HD027880NICHD NIH HHS U24 HD095254NICHD NIH HHS UG1 HD021364NICHD NIH HHS UG1 HD021385NICHD NIH HHS UG1 HD027851NICHD NIH HHS UG1 HD027853NICHD NIH HHS UG1 HD027856NICHD NIH HHS UG1 HD027904NICHD NIH HHS UG1 HD034216NICHD NIH HHS UG1 HD040492NICHD NIH HHS UG1 HD040689NICHD NIH HHS UG1 HD053089NICHD NIH HHS UG1 HD053109NICHD NIH HHS UG1 HD068244NICHD NIH HHS UG1 HD068263NICHD NIH HHS UG1 HD068270NICHD NIH HHS UG1 HD068278NICHD NIH HHS UG1 HD068284NICHD NIH HHS UG1 HD087226NICHD NIH HHS UG1 HD087229
6 · The paper itself

Abstract

Importance: Observational studies often report that anemia and red blood cell (RBC) transfusions are associated with a higher risk of necrotizing enterocolitis (NEC) among extremely low-birthweight (ELBW) infants. Objective: To evaluate whether there is a temporal association between 72-hour hazard periods of exposure to RBC transfusions and NEC among ELBW infants randomized to either higher or lower hemoglobin transfusion thresholds. Design, Setting, and Participants: This post hoc secondary analysis of 1690 ELBW infants who survived to postnatal day 10 enrolled in the Transfusion of Prematures (TOP) randomized multicenter trial between December 1, 2012, and April 12, 2017, was performed between June 2021 and July 2023. Exposures: First, the distribution of RBC transfusions and the occurrence of NEC up to postnatal day 60 were examined. Second, 72-hour posttransfusion periods were categorized as hazard periods and the pretransfusion periods of variable duration as control periods. Then, the risk of NEC in posttransfusion hazard periods was compared with that in pretransfusion control periods, stratifying the risk based on randomization group (higher or lower hemoglobin transfusion threshold group). Main Outcomes and Measures: The primary outcome was incidence of NEC stage 2 or 3. Secondary outcomes included the incidence rates of NEC within five 10-day intervals, taking into account the number of days at risk. Results: Of 1824 ELBW infants randomized during the TOP trial, 1690 were included in the present analysis (mean [SD] gestational age, 26.0 [1.5] weeks; 899 infants [53.2%] were female). After categorizing 4947 hazard periods and 5813 control periods, we identified 133 NEC cases. Fifty-nine of these cases (44.4%) occurred during hazard periods. Baseline and clinical characteristics of infants with NEC during hazard periods did not differ from those of infants with NEC during control periods. The risk of NEC was 11.9 per 1000 posttransfusion hazard periods and 12.7 per 1000 control periods (adjusted risk ratio, 0.95; 95% CI, 0.68-1.32; P = .74). This risk did not differ significantly between randomization groups, but the incidence rate of NEC per 1000 days peaked between postnatal days 20 and 29 in the lower hemoglobin transfusion threshold group. Conclusions and Relevance: The findings of this post hoc analysis suggest that, among ELBW infants with the hemoglobin ranges occurring in the TOP trial, exposure to RBC transfusions was not temporally associated with a higher risk of NEC during 72-hour posttransfusion hazard periods. Given that the incidence rate of NEC peaked between postnatal days 20 and 29 among infants with lower hemoglobin values, a more in-depth examination of this at-risk period using larger data sets is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT01702805.

Indexed as

Enterocolitis, NecrotizingErythrocyte TransfusionFemaleHumansIncidenceInfant, Extremely Low Birth WeightInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMaleTime Factors

Identifiers

PMID38700862
PMCPMC11069076

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.