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Study Comparing Platelet Transfusion Volumes in Premature Babies
Sponsor: University College Dublin
Summary
Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby. Participants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls/kg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls/kg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.
Official title: Platelets for Neonatal Transfusion - 3: (PlaNeT-3) a Randomised Controlled Trial of Platelet Transfusion Volumes in Babies Born at Less Than or Equal to 32+0 Weeks Gestation or Less Than 1500g
Key Details
Gender
All
Age Range
Any - 32 Weeks
Study Type
INTERVENTIONAL
Enrollment
370
Start Date
2023-10-28
Completion Date
2028-08
Last Updated
2023-10-23
Healthy Volunteers
No
Conditions
Interventions
Dose of platelet transfusion
Intervention is using a lower (5ml/kg) compared to usual (15ml/kg) dose of platelets for transfusion in non-bleeding babies born at or before 32 weeks in NICU
Locations (1)
National Maternity Hospital
Dublin, Ireland