Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants

Haresh Kirpalani; Edward F Bell; Susan R Hintz; Sylvia Tan; Barbara Schmidt; Aasma S Chaudhary; Karen J Johnson; Margaret M Crawford; Jamie E Newman; Betty R Vohr; Waldemar A Carlo; Carl T D'Angio; Kathleen A Kennedy; Robin K Ohls; Brenda B Poindexter; Kurt Schibler; Robin K Whyte; John A Widness; John A F Zupancic; Myra H Wyckoff; William E Truog; Michele C Walsh; Valerie Y Chock; Abbot R Laptook; Gregory M Sokol; Bradley A Yoder; Ravi M Patel; C Michael Cotten; Melissa F Carmen; Uday Devaskar; Sanjay Chawla; Ruth Seabrook; Rosemary D Higgins; Abhik Das; Eunice Kennedy Shriver NICHD Neonatal Research Network

doi:10.1056/NEJMoa2020248

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Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants

Journal article

Open access

Peer reviewed

Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants

Haresh Kirpalani, Edward F Bell, Susan R Hintz, Sylvia Tan, Barbara Schmidt, Aasma S Chaudhary, Karen J Johnson, Margaret M Crawford, Jamie E Newman, Betty R Vohr, …

The New England journal of medicine, Vol.383(27), pp.2639-2651

12/31/2020

DOI: 10.1056/NEJMoa2020248

PMCID: PMC8487591

PMID: 33382931

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https://doi.org/10.1056/nejmoa2020248View

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Abstract

Limited data suggest that higher hemoglobin thresholds for red-cell transfusions may reduce the risk of cognitive delay among extremely-low-birth-weight infants with anemia. We performed an open, multicenter trial in which infants with a birth weight of 1000 g or less and a gestational age between 22 weeks 0 days and 28 weeks 6 days were randomly assigned within 48 hours after delivery to receive red-cell transfusions at higher or lower hemoglobin thresholds until 36 weeks of postmenstrual age or discharge, whichever occurred first. The primary outcome was a composite of death or neurodevelopmental impairment (cognitive delay, cerebral palsy, or hearing or vision loss) at 22 to 26 months of age, corrected for prematurity. A total of 1824 infants (mean birth weight, 756 g; mean gestational age, 25.9 weeks) underwent randomization. There was a between-group difference of 1.9 g per deciliter (19 g per liter) in the pretransfusion mean hemoglobin levels throughout the treatment period. Primary outcome data were available for 1692 infants (92.8%). Of 845 infants in the higher-threshold group, 423 (50.1%) died or survived with neurodevelopmental impairment, as compared with 422 of 847 infants (49.8%) in the lower-threshold group (relative risk adjusted for birth-weight stratum and center, 1.00; 95% confidence interval [CI], 0.92 to 1.10; P = 0.93). At 2 years, the higher- and lower-threshold groups had similar incidences of death (16.2% and 15.0%, respectively) and neurodevelopmental impairment (39.6% and 40.3%, respectively). At discharge from the hospital, the incidences of survival without severe complications were 28.5% and 30.9%, respectively. Serious adverse events occurred in 22.7% and 21.7%, respectively. In extremely-low-birth-weight infants, a higher hemoglobin threshold for red-cell transfusion did not improve survival without neurodevelopmental impairment at 22 to 26 months of age, corrected for prematurity. (Funded by the National Heart, Lung, and Blood Institute and others; TOP ClinicalTrials.gov number, NCT01702805.).

Algorithms

Anemia - blood

Anemia - mortality

Anemia - therapy

Cerebral Palsy - prevention & control

Cognition Disorders - prevention & control

Erythrocyte Transfusion - adverse effects

Hearing Loss - prevention & control

Hemoglobins - analysis

Humans

Infant, Extremely Low Birth Weight - blood

Infant, Extremely Premature - blood

Infant, Newborn - blood

Infant, Premature - blood

Infant, Premature, Diseases - blood

Infant, Premature, Diseases - mortality

Infant, Premature, Diseases - therapy

Neurodevelopmental Disorders - prevention & control

Survival Rate

Vision Disorders - prevention & control

Details

Title: Subtitle: Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants
Creators: Haresh Kirpalani
Edward F Bell
Susan R Hintz
Sylvia Tan
Barbara Schmidt
Aasma S Chaudhary
Karen J Johnson
Margaret M Crawford
Jamie E Newman
Betty R Vohr
Waldemar A Carlo
Carl T D'Angio
Kathleen A Kennedy
Robin K Ohls
Brenda B Poindexter
Kurt Schibler
Robin K Whyte
John A Widness
John A F Zupancic
Myra H Wyckoff
William E Truog
Michele C Walsh
Valerie Y Chock
Abbot R Laptook
Gregory M Sokol
Bradley A Yoder
Ravi M Patel
C Michael Cotten
Melissa F Carmen - University of Rochester
Uday Devaskar
Sanjay Chawla
Ruth Seabrook
Rosemary D Higgins
Abhik Das
Eunice Kennedy Shriver NICHD Neonatal Research Network
Resource Type: Journal article
Publication Details: The New England journal of medicine, Vol.383(27), pp.2639-2651
DOI: 10.1056/NEJMoa2020248
PMID: 33382931
PMCID: PMC8487591
NLM abbreviation: N Engl J Med
ISSN: 0028-4793
eISSN: 1533-4406
Grant note: U01 HL112776 / NHLBI NIH HHS UG1 HD068244 / NICHD NIH HHS UG1 HD053109 / NICHD NIH HHS UG1 HD027904 / NICHD NIH HHS U24 HD095254 / NICHD NIH HHS U01 HL112748 / NHLBI NIH HHS KL2 TR003168 / NCATS NIH HHS U10 HD027904 / NICHD NIH HHS
Language: English
Date published: 12/31/2020
Academic Unit: Stead Family Department of Pediatrics; Neonatology
Record Identifier: 9984353881002771

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