| Trial name or title |
Effect of transfusion of washed red blood cells on neonatal outcome: a randomised controlled trial |
| Methods |
Randomised, multicentre, controlled trial |
| Participants |
Infants born with a gestational age up to and including 28 weeks and 6 days |
| Interventions |
Eligible infants will be randomly allocated to receive either washed or non‐washed standard non‐irradiated, leukodepleted allogeneic packed red blood cells. |
| Outcomes |
The primary outcome is a composite of mortality (defined as death of a live born infant > 48 hours of age) and/or major neonatal morbidities associated with organ dysfunction or failure following transfusion, until discharge from neonatal intensive care unit. Major neonatal morbidity is defined as one or more of bronchopulmonary dysplasia (oxygen and/or respiratory support ‐ intubation/continuous positive airway pressure/high‐flow nasal cannula oxygen ≥ 2 L/min) for any portion of the day at 36 weeks and 0 days corrected gestational age), brain injury defined as intraventricular haemorrhage (grades 3 and 4), retinopathy of prematurity (> stage 2), and necrotising enterocolitis (based on a grading of stage 2 or greater). Secondary outcomes include nosocomial infection (blood culture positive sepsis diagnosed > 48 hours after birth), length of mechanical ventilation, and length of primary admission |
| Starting date |
Not yet recruiting |
| Contact information |
michael.stark@adelaide.edu.au |
| Notes |
Trial ID: ACTRN12614000419662 |
