Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants.
Algorithms
Anemia
/ blood
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
Neurodevelopmental Disorders
/ prevention & control
Survival Rate
Vision Disorders
/ prevention & control
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
31 12 2020
31 12 2020
Historique:
entrez:
31
12
2020
pubmed:
1
1
2021
medline:
21
1
2021
Statut:
ppublish
Résumé
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.).
Sections du résumé
BACKGROUND
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
Identifiants
pubmed: 33382931
doi: 10.1056/NEJMoa2020248
pmc: PMC8487591
mid: NIHMS1727605
doi:
Substances chimiques
Hemoglobins
0
Banques de données
ClinicalTrials.gov
['NCT01702805']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
2639-2651Subventions
Organisme : NHLBI NIH HHS
ID : U01 HL112776
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD068244
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL112748
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD027904
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD027904
Pays : United States
Organisme : NCATS NIH HHS
ID : KL2 TR003168
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD053109
Pays : United States
Organisme : NICHD NIH HHS
ID : U24 HD095254
Pays : United States
Investigateurs
Pablo J Sánchez
(PJ)
Leif D Nelin
(LD)
Sudarshan R Jadcherla
(SR)
Patricia Luzader
(P)
Christine A Fortney
(CA)
Julie Gutentag
(J)
Christopher J Timan
(CJ)
Kristi Small
(K)
Rox Ann Sullivan
(RA)
Lina Yoseff-Salameh
(L)
Jacqueline McCool
(J)
Melanie Stein
(M)
Erin Fearns
(E)
Aubrey Fowler
(A)
Jennifer Grothause
(J)
Stephanie Burkhardt
(S)
Jessica Purnell
(J)
Mary Ann Nelin
(MA)
Helen Carey
(H)
Lindsay Pietruszewski
(L)
Margaret Sullivan
(M)
Julie Shadd
(J)
Jennifer Notestine
(J)
Cole Hague
(C)
Erna Clark
(E)
Michelle Chao
(M)
Courtney Park
(C)
Hallie Baugher
(H)
Demi R Beckford
(DR)
Bethany Miller
(B)
Laura Marzec
(L)
Kyrstin Warnimont
(K)
Martin Keszler
(M)
Angelita M Hensman
(AM)
Barbara Alksninis
(B)
Robert T Burke
(RT)
Melinda Caskey
(M)
Laurie Hoffman
(L)
Katharine Johnson
(K)
Mary L Keszler
(ML)
Andrea Knoll
(A)
Teresa M Leach
(TM)
Emily Little
(E)
Elisabeth C McGowan
(EC)
Lucille St Pierre
(LS)
Bonnie E Stephens
(BE)
Elisa Vieira
(E)
Victoria E Watson
(VE)
Anna Maria Hibbs
(AM)
Nancy S Newman
(NS)
Allison H Payne
(AH)
Deanne E Wilson-Costello
(DE)
Bonnie S Siner
(BS)
Monika Bhola
(M)
Gulgun Yalcinkaya
(G)
Eugenia K Pallotto
(EK)
Howard W Kilbride
(HW)
Cheri Gauldin
(C)
Anne Holmes
(A)
Kathy Johnson
(K)
Allison Scott
(A)
Stephanie L Merhar
(SL)
Tanya E Cahill
(TE)
Cathy Grisby
(C)
Kristin Kirker
(K)
Sandra Wuertz
(S)
Ronald N Goldberg
(RN)
Ricki F Goldstein
(RF)
William F Malcolm
(WF)
Patricia L Ashley
(PL)
Deesha Mago-Shah
(D)
Mollie Warren
(M)
Joanne Finkle
(J)
Kimberley A Fisher
(KA)
Kathryn E Gustafson
(KE)
Matthew M Laughon
(MM)
Carl L Bose
(CL)
Janice Bernhardt
(J)
Janice Wereszczak
(J)
Diane Warner
(D)
Jennifer Talbert
(J)
Cindy Clark
(C)
Stephen D Kicklighter
(SD)
Alexandra Bentley
(A)
Laura Edwards
(L)
Ginger Rhodes-Ryan
(G)
Donna White
(D)
David P Carlton
(DP)
Barbara J Stoll
(BJ)
Ira Adams-Chapman
(I)
Yvonne Loggins
(Y)
Ellen C Hale
(EC)
Diane Bottcher
(D)
Sheena L Carter
(SL)
Salathiel Kendrick-Allwood
(S)
Maureen Mulligan LaRossa
(M)
Colleen Mackie
(C)
Gloria Smikle
(G)
Lynn C Comerford
(LC)
Andrew A Bremer
(AA)
Stephanie Wilson Archer
(S)
Brenda B Poindexter
(BB)
Heidi Harmon
(H)
Lu Ann Papile
(LA)
Abbey C Hines
(AC)
Dianne E Herron
(DE)
Susan Gunn
(S)
Lucy Smiley
(L)
Amir M Khan
(AM)
Jon E Tyson
(JE)
Andrea F Duncan
(AF)
Elizabeth Allain
(E)
Julie Arldt-McAlister
(J)
Katrina Burson
(K)
Allison G Dempsey
(AG)
Elizabeth Eason
(E)
Patricia W Evans
(PW)
Carmen Garcia
(C)
Charles Green
(C)
Donna J Hall
(DJ)
Margarita Jiminez
(M)
Janice John
(J)
Patrick M Jones
(PM)
M Layne Lillie
(ML)
Karen Martin
(K)
Sara C Martin
(SC)
Carrie M Mason
(CM)
Georgia E McDavid
(GE)
Shannon L McKee
(SL)
Michelle Poe
(M)
Kimberly Rennie
(K)
Shawna L Rodgers
(SL)
Saba Khan Siddiki
(SK)
Daniel Sperry
(D)
Emily K Stephens
(EK)
Patti L Pierce Tate
(PL)
Sharon L Wright
(SL)
Catherine Levy
(C)
Carla M Bann
(CM)
Marie G Gantz
(MG)
Jeanette O'Donnell Auman
(J)
Donald J Brambilla
(DJ)
Jenna Gabrio
(J)
Carolyn M Petrie Huitema
(CM)
David Leblond
(D)
Annie vonLehmden
(A)
Dennis Wallace
(D)
Kristin M Zaterka-Baxter
(KM)
Krisa P Van Meurs
(KP)
David K Stevenson
(DK)
M Bethany Ball
(MB)
Barbara Bentley
(B)
Maria Elena DeAnda
(ME)
Anne M DeBattista
(AM)
Beth Earhart
(B)
Lynne C Huffman
(LC)
Casey E Krueger
(CE)
Ryan E Lucash
(RE)
Melinda S Proud
(MS)
Elizabeth N Reichert
(EN)
Dharshi Sivakumar
(D)
Heather Taylor
(H)
Hali E Weiss
(HE)
Namasivayam Ambalavanan
(N)
Monica V Collins
(MV)
Shirley S Cosby
(SS)
Myriam Peralta-Carcelen
(M)
Fred J Biasini
(FJ)
Kristen C Johnston
(KC)
Mary Beth Moses
(MB)
Tara E McNair
(TE)
Vivien A Phillips
(VA)
Richard V Rector
(RV)
Sally Whitley
(S)
Kristy A Domnanovich
(KA)
Sheree York Chapman
(S)
Kimberlly Stringer
(K)
Morissa Ladinsky
(M)
Chantel Jno-Finn
(C)
Meena Garg
(M)
Isabell B Purdy
(IB)
Teresa Chanlaw
(T)
Rachel Geller
(R)
Tarah T Colaizy
(TT)
Jane E Brumbaugh
(JE)
Heidi M Harmon
(HM)
Jacky R Walker
(JR)
Claire A Goeke
(CA)
Mendi L Schmelzel
(ML)
Diane L Eastman
(DL)
Kristi L Watterberg
(KL)
Conra Backstrom Lacy
(C)
Janell Fuller
(J)
Mary Hanson
(M)
Carol Hartenberger
(C)
Elizabeth Kuan
(E)
Jean R Lowe
(JR)
Sandra Sundquist Beauman
(S)
Sara B DeMauro
(SB)
Eric C Eichenwald
(EC)
Soraya Abbasi
(S)
Toni Mancini
(T)
Dara M Cucinotta
(DM)
Judy C Bernbaum
(JC)
Marsha Gerdes
(M)
Hallam Hurt
(H)
Jonathan Snyder
(J)
Ronnie Guillet
(R)
Gary J Myers
(GJ)
Kyle Binion
(K)
Caitlin Fallone
(C)
Osman Farooq
(O)
Julianne Hunn
(J)
Rosemary L Jensen
(RL)
Joan Merzbach
(J)
Constance Orme
(C)
Premini Sabaratnam
(P)
Ann Marie Scorsone
(AM)
Holly I M Wadkins
(HIM)
Kelley Yost
(K)
Satyan Lakshminrusimha
(S)
Anne Marie Reynolds
(AM)
Stephanie Guilford
(S)
Michelle E Hartley-McAndrews
(ME)
Ashley Williams
(A)
William Zorn
(W)
Emily Li
(E)
Jennifer Donato
(J)
Kimberly G McKee
(KG)
Kelly R Coleman
(KR)
Alison Kent
(A)
Luc P Brion
(LP)
Roy J Heyne
(RJ)
Diana M Vasil
(DM)
Sally S Adams
(SS)
Maria M De Leon
(MM)
Frances Eubanks
(F)
Alicia Guzman
(A)
Elizabeth Heyne
(E)
Lizette E Lee
(LE)
Linda A Madden
(LA)
E Rebecca McDougald
(ER)
Lara Pavageau
(L)
Anna E Puentez
(AE)
Pollieanna Sepulveda
(P)
Cathy Twell Boatman
(C)
Kristine Tolentino-Plata
(K)
Azucena Vera
(A)
Jillian Waterbury
(J)
Mariana Baserga
(M)
Stephen D Minton
(SD)
Mark J Sheffield
(MJ)
Carrie A Rau
(CA)
Sarah Winter
(S)
Shawna Baker
(S)
Jill Burnett
(J)
Susan Christensen
(S)
Laura Cole Bledsoe
(L)
Sean Cunningham
(S)
Jennifer O Elmont
(JO)
Becky Hall
(B)
Trisha Marchant
(T)
Earl Maxson
(E)
Kandace M McGrath
(KM)
Hena G Mickelsen
(HG)
Galina Morshedzadeh
(G)
D Melody Parry
(DM)
Brixen A Reich
(BA)
Susan T Schaefer
(ST)
Ashley L Stuart
(AL)
Kelly Stout
(K)
Kimberlee Weaver-Lewis
(K)
Kathryn D Woodbury
(KD)
Seetha Shankaran
(S)
Beena G Sood
(BG)
Rebecca Bara
(R)
Prashant Agarwal
(P)
Monika Bajaj
(M)
Kirsten Childs
(K)
Melissa February
(M)
Laura Goldston
(L)
Mary E Johnson
(ME)
Girija Natarajan
(G)
Bogdan Panaitescu
(B)
Eunice Woldt
(E)
John Barks
(J)
Martha Carlson
(M)
Diane F White
(DF)
Naomi L Luban
(NL)
Cassandra Josephson
(C)
David F Friedman
(DF)
Deborah A Sesok-Pizzini
(DA)
Nancy M Heddle
(NM)
Christine A Gleason
(CA)
Marilee C Allen
(MC)
Robert J Boyle
(RJ)
Traci Clemons
(T)
Mary E D'Alton
(ME)
Abhik Das
(A)
Catherine S Manno
(CS)
Traci H Mondoro
(TH)
Menachem Miodovnik
(M)
T Michael O'Shea
(TM)
Robin Steinhorn
(R)
Steven J Weiner
(SJ)
Marian Willinger
(M)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 Massachusetts Medical Society.
Références
Transfus Med Rev. 2016 Oct;30(4):165-73
pubmed: 27424006
Arch Ophthalmol. 2005 Jul;123(7):991-9
pubmed: 16009843
Semin Perinatol. 2012 Aug;36(4):244-7
pubmed: 22818544
J Pediatr. 2011 Sep;159(3):371-376.e1-3
pubmed: 21489555
JAMA. 2016 Mar 1;315(9):889-97
pubmed: 26934258
J Pediatr. 2011 Sep;159(3):359-61
pubmed: 21679967
Ann Surg. 1978 Jan;187(1):1-7
pubmed: 413500
Pediatrics. 2005 Jun;115(6):1685-91
pubmed: 15930233
JAMA. 2003 Apr 16;289(15):1950-6
pubmed: 12697797
J Perinatol. 2014 Dec;34(12):921-5
pubmed: 24921411
Pediatrics. 2012 Mar;129(3):529-40
pubmed: 22351894
Pediatrics. 2017 Apr;139(4):
pubmed: 28325811
Ophthalmology. 2016 Apr;123(4):796-803
pubmed: 26854038
J Pediatr. 1978 Apr;92(4):529-34
pubmed: 305471
N Engl J Med. 2020 Feb 13;382(7):674-678
pubmed: 32053307
J Perinatol. 2003 Sep;23(6):451-6
pubmed: 13679930
Arch Pediatr Adolesc Med. 2011 May;165(5):443-50
pubmed: 21199970
Transfusion. 2014 Jan;54(1):104-8
pubmed: 23672455
JAMA. 2020 Aug 11;324(6):560-570
pubmed: 32780138
Transfusion. 2015 Jun;55(6):1340-6
pubmed: 25652740
N Engl J Med. 2020 Jan 16;382(3):233-243
pubmed: 31940698
Pediatrics. 2009 Jan;123(1):207-13
pubmed: 19117884
J Pediatr. 1996 Nov;129(5):680-7
pubmed: 8917234
JAMA. 2012 Oct 10;308(14):1443-51
pubmed: 23045213
Semin Perinatol. 2012 Aug;36(4):269-76
pubmed: 22818547
Cochrane Database Syst Rev. 2011 Nov 09;(11):CD000512
pubmed: 22071798
J Pediatr. 2006 Sep;149(3):301-307
pubmed: 16939737
Pediatrics. 2010 Feb;125(2):e214-24
pubmed: 20100760
Semin Perinatol. 2017 Feb;41(1):80-91
pubmed: 27866662
CMAJ. 1992 Dec 15;147(12):1781-92
pubmed: 1458420
Dev Med Child Neurol. 2006 Jun;48(6):424-8
pubmed: 16700931
Am J Epidemiol. 1987 Dec;126(6):1165-72
pubmed: 3687923
J Pediatr. 2000 Feb;136(2):220-4
pubmed: 10657829
J Pediatr. 2012 Sep;161(3):417-421.e1
pubmed: 22494873
JAMA. 2019 Dec 10;322(22):2179-2190
pubmed: 31821429
Eur J Pediatr. 1997 Jan;156(1):47-50
pubmed: 9007491
J Med Ethics. 2005 Sep;31(9):548-53
pubmed: 16131559