Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Effects of Liberal vs Restrictive Transfusion Thresholds on Survival and Neurocognitive Outcomes in Extremely Low-Birth-Weight Infants: The ETTNO Randomized Clinical Trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Prevalence of Bicuspid Aortic Valve and Associated Aortopathy in Newborns in Copenhagen, Denmark

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Assessing Progress in Health Care Quality Through the Lens of COVID-19

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Evaluating Non-Statistically Significant Results From Trials in Practice-Reply

    Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

  4. Association of Lumbar Puncture With Spinal Hematoma in Patients With and Without Coagulopathy

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Antibiotic regimens for early‐onset neonatal sepsis (Protocol)

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Antibiotic regimens for late‐onset neonatal sepsis (Protocol)

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Continuing decline in the prevalence of cerebral palsy in Denmark for birth years 2008–2013

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

Importance: Red blood cell transfusions are commonly administered to infants weighing less than 1000 g at birth. Evidence-based transfusion thresholds have not been established. Previous studies have suggested higher rates of cognitive impairment with restrictive transfusion thresholds.

Objective: To compare the effect of liberal vs restrictive red blood cell transfusion strategies on death or disability.

Design, Setting, and Participants: Randomized clinical trial conducted in 36 level III/IV neonatal intensive care units in Europe among 1013 infants with birth weights of 400 g to 999 g at less than 72 hours after birth; enrollment took place between July 14, 2011, and November 14, 2014, and follow-up was completed by January 15, 2018.

Interventions: Infants were randomly assigned to liberal (n = 492) or restrictive (n = 521) red blood cell transfusion thresholds based on infants' postnatal age and current health state.

Main Outcome and Measures: The primary outcome, measured at 24 months of corrected age, was death or disability, defined as any of cognitive deficit, cerebral palsy, or severe visual or hearing impairment. Secondary outcome measures included individual components of the primary outcome, complications of prematurity, and growth.

Results: Among 1013 patients randomized (median gestational age at birth, 26.3 [interquartile range {IQR}, 24.9-27.6] weeks; 509 [50.2%] females), 928 (91.6%) completed the trial. Among infants in the liberal vs restrictive transfusion thresholds groups, respectively, incidence of any transfusion was 400/492 (81.3%) vs 315/521 (60.5%); median volume transfused was 40 mL (IQR, 16-73 mL) vs 19 mL (IQR, 0-46 mL); and weekly mean hematocrit was 3 percentage points higher with liberal thresholds. Among infants in the liberal vs restrictive thresholds groups, the primary outcome occurred in 200/450 (44.4%) vs 205/478 (42.9%), respectively, for a difference of 1.6% (95% CI, -4.8% to 7.9%; P = .72). Death by 24 months occurred in 38/460 (8.3%) vs 44/491 (9.0%), for a difference of -0.7% (95% CI, -4.3% to 2.9%; P = .70), cognitive deficit was observed in 154/410 (37.6%) vs 148/430 (34.4%), for a difference of 3.2% (95% CI, -3.3% to 9.6%; P = .47), and cerebral palsy occurred in 18/419 (4.3%) vs 25/443 (5.6%), for a difference of -1.3% (95% CI, -4.2% to 1.5%; P = .37), in the liberal vs the restrictive thresholds groups, respectively. In the liberal vs restrictive thresholds groups, necrotizing enterocolitis requiring surgical intervention occurred in 20/492 (4.1%) vs 28/518 (5.4%); bronchopulmonary dysplasia occurred in 130/458 (28.4%) vs 126/485 (26.0%); and treatment for retinopathy of prematurity was required in 41/472 (8.7%) vs 38/492 (7.7%). Growth at follow-up was also not significantly different between groups.

Conclusions and Relevance: Among infants with birth weights of less than 1000 g, a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.

Trial Registration: ClinicalTrials.gov Identifier: NCT01393496.

OriginalsprogEngelsk
TidsskriftJAMA - Journal of the American Medical Association
Vol/bind324
Udgave nummer6
Sider (fra-til)560-570
Antal sider11
ISSN0002-9955
DOI
StatusUdgivet - 11 aug. 2020

ID: 61530621