Evidence map›Paper›PMID 40375228›Full record

ArticleBMC pediatrics2025

The transfusion of prematures early school age follow-up (TOP 5): protocol for a longitudinal cohort study.

Amy L Conrad, Sara B DeMauro, Haresh Kirpalani, Kristina Ziolkowski, Susan R Hintz, Betty R Vohr, Victoria Watson, Tarah T Colaizy, Edward F Bell, Jane E Brumbaugh and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2025. 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 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Observational
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

14 authors.

Amy L ConradUniversity of Iowa, Iowa City, USA. Amy-L-Conrad@uiowa.edu.
Sara B DeMauroChildren's Hospital of Philadelphia, Philadelphia, USA.
Haresh KirpalaniChildren's Hospital of Philadelphia, Philadelphia, USA.
Kristina ZiolkowskiChildren's Hospital of Philadelphia, Philadelphia, USA.
Susan R HintzStanford University School of Medicine, Stanford, USA.
Betty R VohrWomen & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, USA.
Victoria WatsonWomen & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, USA.
Tarah T ColaizyUniversity of Iowa, Iowa City, USA.
Edward F BellUniversity of Iowa, Iowa City, USA.
Jane E BrumbaughMayo Clinic College of Medicine and Science, Rochester, USA.
Carla M BannAnalytics Division, RTI International, Research Triangle Park, USA.
Sylvia M TanAnalytics Division, RTI International, Research Triangle Park, USA.
Jamie E NewmanAnalytics Division, RTI International, Research Triangle Park, USA.
Abhik DasAnalytics Division, RTI International, Research Triangle Park, USA.

Funding

Neonatal Research Network Data Coordinating Center (DCC) 2023-2028U24HD095254 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI Abhik Das · 2018 to 2026
$70.2M
Data Ctr for the Cooperative Neonatal Research NetworkU01HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 1998 to 2007
$21.8M
Transfusion of Prematurity Early School Age Follow-up (TOP 5) CCCUH3HL143204 · NHLBI · UNIVERSITY OF IOWA · PI CONRAD, AMY LYNN, DEMAURO, SARA BONAMO · 2019 to 2024
$3.3M
Transfusion of Prematurity Early School Age Follow-up (TOP 5) CCCUG3HL143204 · NHLBI · UNIVERSITY OF IOWA · PI DEMAURO, SARA BONAMO, NOPOULOS, PEGGY C · 2018 to 2018
$634k
National Center for Advancing Translational Sciences (NCATS) UL1 TR42, UL1 TR77National Center for Advancing Translational Sciences (NCATS) UL1 TR442, UL1 TR454, UL1 TR1117National Center for Advancing Translational Sciences (NCATS) UL1 TR6, UL1 TR41National Center for Advancing Translational Sciences (NCATS) UL1 TR93, UL1 TR105NHLBI NIH HHS UG3 HL143204NHLBI NIH HHS UG3HL143204, U24HL143216NHLBI NIH HHS UH3 HL143204NICHD NIH HHS U01 HD036790NICHD NIH HHS U24 HD095254NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD21385, UG1 HD27851NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD27853, UG1 HD27856NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD27880,UG1 HD27904NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD34216, U10 HD36790NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD40492, UG1 HD40689NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD53109, UG1 HD68244NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD68263, UG1 HD68284NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD68270, UG1 HD68278NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD87226, UG1 HD40461NIH National Institutes of Health – Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UGI HD21373, UG1 HD21364
6 · The paper itself

Abstract

backgroundAnemia of prematurity is a common concern for extremely low birth weight (ELBW) patients in the neonatal intensive care unit. The hemoglobin threshold at which the benefits of red blood cell transfusion outweigh the risks is unknown. The NICHD Neonatal Research Network Transfusion of Prematures (TOP) Trial evaluated whether higher (more liberal) hemoglobin transfusion thresholds resulted in improved survival without neurodevelopmental impairment at 22-26 months' corrected age. A total of 1824 ELBW infants born at 22-28 weeks' gestation were enrolled in the trial and randomized to either a restrictive or liberal set of red blood cell transfusion thresholds. Longer-term impacts of different transfusion thresholds in treatment for anemia of prematurity remain unknown. The Transfusion of Prematures Early School Age Follow-up (TOP 5) Study extends follow-up of all surviving children enrolled in the TOP Trial until early school age. It aims to assess longer-term cognitive and functional effects of differing transfusion thresholds in the newborn period for anemia in this large, multicenter cohort.

methodsParents of surviving trial participants complete telephone questionnaires when their children are 3 and 4 years' corrected age. A single in-person study visit takes place at early school age (5 years, 0 months to 7 years, 11 months' corrected age). Children undergo a multidimensional assessment of functional outcomes, and parents complete a battery of questionnaires. DISCUSSION: The TOP 5 Study will be the largest and most comprehensive evaluation to date of the functional early school age outcomes of children managed with different red blood cell transfusion thresholds during infancy for treatment of anemia of prematurity. This will substantially improve understanding of the longer-term neurological and functional outcomes of different transfusion thresholds; provide more refined evaluation of cognition, executive function, school readiness, motor skills, adaptive functioning, and behavior in former extremely preterm infants; and inform future clinical decision-making for treating anemia of prematurity.

trial registrationClinicaltrials.gov ID: NCT01702805. Primary trial registration 10/05/2012; modified to include follow-up through school age 12/20/2018. This manuscript reflects version 3 of the trial protocol, dated 12/07/2020.

Indexed as

AnemiaAnemia, NeonatalErythrocyte TransfusionInfant, Premature, DiseasesChild, PreschoolFemaleFollow-Up StudiesHemoglobinsHumansInfantInfant, Extremely Low Birth WeightInfant, NewbornInfant, PrematureLongitudinal StudiesMaleMulticenter Studies as TopicHemoglobinsAnemiaChild behaviorChild developmentNeurodevelopmentOutcomesPrematurityTransfusion

Identifiers

PMID40375228
PMCPMC12080018

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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.