Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial: The BASE Trial (BASE)

Research summary

Sodium bicarbonate is widely,but not universally,used to treat metabolic acidosis in very preterm babies but the evidence underpinning its use is poor. The BASE trial aims to answer the question,‘In very preterm babies with metabolic acidosis,does giving them sodium bicarbonate or not impact on their health and development in the short and long term?’ The primary objective of the BASE trial is to evaluate the effect of sodium bicarbonate on survival to discharge from neonatal care without major morbidity. In this randomised controlled trial,3,764 very preterm babies with metabolic acidosis will be allocated at random to either routine use of sodium bicarbonate infusion or no routine use of sodium bicarbonate infusion. We will compare survival to discharge from neonatal care without the occurrence of major illnesses during neonatal care between the two groups to find out whether giving sodium bicarbonate or not affects very preterm babies’ health in the short term. Babies will also be followed up until they are 24 months of age corrected for prematurity to assess whether there are any longer-term effects of giving sodium bicarbonate or not on children’s development. This is a multicentre,pragmatic,open-label,two-arm,parallel-group,randomised controlled trial. The trial includes a 12-month pilot phase,with criteria at the end of this period to decide whether or not to progress to the main trial. The trial overall has a 3-year recruitment period.

Principal Investigator

Dr Mark Anthony

Contact us

Email: neonatal.research@ouh.nhs.uk

IRAS number

1007672