The BASE Trial: Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial
Research type
Research Study
Full title
Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial: The BASE Trial
IRAS ID
1007672
Contact name
Sabita Uthaya
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
ISRCTN Number
ISRCTN18260410
Research summary
Metabolic acidosis is a build-up of acid in the bloodstream which has various causes. In the UK, 8,000 babies are born very preterm each year and many will develop metabolic acidosis during their stay on a neonatal unit.
Sodium bicarbonate is widely, but not universally, used to treat metabolic acidosis in very preterm babies but the evidence underpinning its use is poor. Some doctors believe that giving sodium bicarbonate lowers acid levels in the bloodstream and improves the functioning of the heart, but others believe sodium bicarbonate raises acid levels in the cells of the body which can be harmful in the short and long-term by affecting blood flow to the brain and other tissues in the body. The two approaches of using sodium bicarbonate, or not, for episodes of metabolic acidosis are commonly used across the UK, so there is nothing new about either type of care. The reason practice differs widely is because the impact and effectiveness of sodium bicarbonate in very preterm babies has never been properly studied.
We want to answer the question, ‘In very preterm babies with metabolic acidosis, does treating them with sodium bicarbonate or not impact on their health and development in the short and long term?’
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.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0244
Date of REC Opinion
2 Nov 2023
REC opinion
Favourable Opinion