TY - JOUR
T1 - Two-year outcomes following a randomised platelet transfusion trial in preterm infants
AU - Moore, Carmel Maria
AU - D'Amore, Angela
AU - Fustolo-Gunnink, Suzanne
AU - Hudson, Cara
AU - Newton, Alice
AU - Santamaria, BeatrizLopez
AU - Deary, Alison
AU - Hodge, Renate
AU - Hopkins, Valerie
AU - Mora, Ana
AU - Llewelyn, Charlotte
AU - Venkatesh, Vidheya
AU - Khan, Rizwan
AU - Willoughby, Karen
AU - Onland, Wes
AU - Fijnvandraat, Karin
AU - New, Helen V.
AU - Clarke, Paul
AU - Lopriore, Enrico
AU - Watts, Timothy
AU - Stanworth, Simon
AU - Curley, Anna
N1 - Funding Information: This work was supported by the National Health Service Blood and Transplant Research and Development Committee (reference number BS06/1); Sanquin Research, Amsterdam (grant PPOC-12-012027); Addenbrooke’s Charitable Trust; the Neonatal Breath of Life Fund 9145; the National Institute for Health Research Clinical Research Network; the National Maternity Hospital Foundation and the Health Service Executive. Publisher Copyright: © 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/9/1
Y1 - 2023/9/1
N2 - Objective: Assess mortality and neurodevelopmental outcomes at 2 years of corrected age in children who participated in the PlaNeT-2/MATISSE (Platelets for Neonatal Transfusion - 2/Management of Thrombocytopenia in Special Subgroup) study, which reported that a higher platelet transfusion threshold was associated with significantly increased mortality or major bleeding compared to a lower one. Design: Randomised clinical trial, enrolling from June 2011 to August 2017. Follow-up was complete by January 2020. Caregivers were not blinded; however, outcome assessors were blinded to treatment group. Setting: 43 level II/III/IV neonatal intensive care units (NICUs) across UK, Netherlands and Ireland. Patients: 660 infants born at less than 34 weeks' gestation with platelet counts less than 50×109/L. Interventions: Infants were randomised to undergo a platelet transfusion at platelet count thresholds of 50×109/L (higher threshold group) or 25×109/L (lower threshold group). Main outcomes measures: Our prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age. Results: Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR 1.54, 95% CI 1.09 to 2.17, p=0.017). Conclusions: Infants randomised to a higher platelet transfusion threshold of 50×109/L compared with 25×109/L had a higher rate of death or significant neurodevelopmental impairment at a corrected age of 2 years. This further supports evidence of harm caused by high prophylactic platelet transfusion thresholds in preterm infants. Trial registration number: ISRCTN87736839.
AB - Objective: Assess mortality and neurodevelopmental outcomes at 2 years of corrected age in children who participated in the PlaNeT-2/MATISSE (Platelets for Neonatal Transfusion - 2/Management of Thrombocytopenia in Special Subgroup) study, which reported that a higher platelet transfusion threshold was associated with significantly increased mortality or major bleeding compared to a lower one. Design: Randomised clinical trial, enrolling from June 2011 to August 2017. Follow-up was complete by January 2020. Caregivers were not blinded; however, outcome assessors were blinded to treatment group. Setting: 43 level II/III/IV neonatal intensive care units (NICUs) across UK, Netherlands and Ireland. Patients: 660 infants born at less than 34 weeks' gestation with platelet counts less than 50×109/L. Interventions: Infants were randomised to undergo a platelet transfusion at platelet count thresholds of 50×109/L (higher threshold group) or 25×109/L (lower threshold group). Main outcomes measures: Our prespecified long-term follow-up outcome was a composite of death or neurodevelopmental impairment (developmental delay, cerebral palsy, seizure disorder, profound hearing or vision loss) at 2 years of corrected age. Results: Follow-up data were available for 601 of 653 (92%) eligible participants. Of the 296 infants assigned to the higher threshold group, 147 (50%) died or survived with neurodevelopmental impairment, as compared with 120 (39%) of 305 infants assigned to the lower threshold group (OR 1.54, 95% CI 1.09 to 2.17, p=0.017). Conclusions: Infants randomised to a higher platelet transfusion threshold of 50×109/L compared with 25×109/L had a higher rate of death or significant neurodevelopmental impairment at a corrected age of 2 years. This further supports evidence of harm caused by high prophylactic platelet transfusion thresholds in preterm infants. Trial registration number: ISRCTN87736839.
KW - Child Development
KW - Intensive Care Units, Neonatal
KW - Neonatology
UR - http://www.scopus.com/inward/record.url?scp=85152210537&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/archdischild-2022-324915
DO - https://doi.org/10.1136/archdischild-2022-324915
M3 - Article
C2 - 36810309
SN - 1359-2998
VL - 108
SP - F452-F457
JO - Archives of disease in childhood. Fetal and neonatal edition
JF - Archives of disease in childhood. Fetal and neonatal edition
IS - 5
M1 - archdischild-2022-325122
ER -