Topic: Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
Trial intervention, Counselling and procedures for obtaining parental consent for the study will commence when the neonate s platelet counts fall below 100 x109/L.
Neonates for whom p
Study Entry : Single Randomisation only
Sponsors
National Blood Service (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained 2. Admission to a participating neonatal intensive care unit (NICU) (includes postnatal transfers) 3. <34 weeks gestational age at birth 4. A platelet count of < 50x10^9/L 5. Cranial ultrasound scan must have been undertaken less than 6 hours prior to randomisation in order to rule out recent major intraventricular hemorrhage (IVH) IVH defined as any haemorrhage (H1, H2 or H3) with ventricular dilatation (V1) (Grade 3 Papile grading, (Papile et al 1978) or any haemorrhage (H1,H2,H3) with parenchymal involvement (P1, P2 or P3) (Grade 4 Papile grading,) within the past 72 hours. If a cranial ultrasound scan (which typically takes a few minutes to complete) has not been undertaken less than 6 hours prior to randomisation it must be performed before the baby can be randomised. Target Gender: Male & Female; Upper Age Limit 34 weeks ; Lower Age Limit 23 weeks
Exclusion criteria
Exclusion criteria: 1. Major/lifethreatening congenital malformations (e.g. chromosomal anomalies, Fanconi?s anaemia, Thrombocytopenia Absent Radius syndrome) 2. Recent major IVH within the last 72 hours i.e. any haemorrhage (H1, H2 or H3) with ventricular dilatation (V1) (Grade 3. Papile grading, or any haemorrhage (H1, H2 or H3) with parenchymal involvement (P1, P2 or P3) (Grade 4 Papile grading) 4. All fetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan 5. Known immune thrombocytopenia or family history of alloimmune thrombocytopenia or maternal antiplatelet antibodies or maternal idiopathic thrombocytopenic purpura 6. Neonates judged by the attending neonatologist to be unlikely to survive more than a few hours at the time of proposed randomisation 7. Neonates who were not given parenteral Vitamin K after birth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who either die or experience a major bleed | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients surviving to go home following a major bleed, censoring at discharge | — |
Countries
England, Ireland, Netherlands, United Kingdom
Outcome results
None listed