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
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
32 Weeks
Healthy volunteers
No
Inclusion Criteria:
* Infants born at or before 32+0 weeks' gestation or less than 1500g at birth
* Written informed consent obtained from parent
* Admission to a participating NICU (includes postnatal transfers)
* Severe Thrombocytopenia (platelet count \<25 x109/L)
* Cranial ultrasound scan undertaken less than 24 hours prior to randomisation shows no recent major intraventricular haemorrhage (IVH) or significant extension of previous haemorrhage.
Exclusion Criteria:
* Major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/VSD), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g., T21, T13, T18, Fanconi's anaemia, Thrombo-cytopenia Absent Radius syndrome).
* Infants on a palliative care pathway
* Neonates within 72 hours of major bleed
* All fetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan.
* Known immune thrombocytopenia or family history of allo-immune thrombocytopenia or maternal anti platelet antibodies or maternal idiopathic thrombocytopenic purpura
* Neonates who did not receive parenteral vitamin K
Primary outcome measure(s)
Death or Major Bleeding — 28 days This outcome assesses the incidence of Death or Major Bleeding
Trial sites (1)
Facility
City
Region
Status
National Maternity Hospital
Dublin
Ireland
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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