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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Sabita Uthaya
s.uthaya@imperial.ac.uk


Miss Catherine Thompsett
base@npeu.ox.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial: The BASE Trial
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Bicarbonate for AcidosiS in very pretErm babies: a randomised clinical trial: The BASE Trial

Recruiting

Open to: All Genders

Age: Neonate

Bath Oxford Leeds Leicester Sunderland Ashford Wolverhampton Norwich London Burnley Luton Lincoln Bolton Birmingham Carshalton Wakefield Watford Gillingham Oldham Nottingham Telford Wirral Romford Tunbridge Wells

Medical Conditions

Metabolic acidosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 in 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 that the impact and effectiveness of sodium bicarbonate in very preterm babies have never been properly studied. The study team want to answer the question, ‘In very preterm babies with metabolic acidosis, does treating them with sodium bicarbonate or not impact their health and development in the short and long term?’

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

20 Feb 2024 01 Jul 2026

In this study, 3,764 babies will be allocated at random to either routine use of sodium bicarbonate infusion or no routine use of sodium bicarbonate infusion. The study 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 and corrected for prematurity to assess whether there are any longer-term effects of giving sodium bicarbonate or not on children’s development.

Sodium bicarbonate is widely, but not universally, used in the management of metabolic acidosis in very preterm babies despite a very low grade of evidence underpinning its use. The BASE study will be the first adequately powered trial to study the impact and effectiveness, both in the short and long term, of the use of sodium bicarbonate to treat metabolic acidosis in very preterm babies.

The two trial arms being compared both represent existing clinical practice in different neonatal units in the UK, i.e.:
• routine use of sodium bicarbonate infusion for episodes of metabolic acidosis
or
• no routine use of sodium bicarbonate infusion for episodes of metabolic acidosis


Very preterm babies with metabolic acidosis

You can take part if:



You may not be able to take part if:


1. Life-threatening condition, or significant congenital anomaly 2. Inborn error of metabolism (known or under active investigation)3. Prior treatment with sodium bicarbonate unless in the context of cardiopulmonary resuscitation or if used as a substitute for normal saline in arterial line infusion.4. Current episode of metabolic acidosis immediately follows cardiopulmonary resuscitation


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal United Hospitals Bath NHS Foundation Trust
    Combe Park
    Bath
    BA1 3NG
  • John Radcliffe Hospital
    Headley Way Headington
    Oxford
    OX3 9DU
  • Leeds General Infirmary
    Great George Street
    Leeds
    LS1 3EX
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • Sunderland Royal Hospital
    Kayll Road
    Sunderland
    SR4 7TP
  • William Harvey Hospital
    Kennington Road Willesborough
    Ashford
    TN24 0LZ
  • The Royal Wolverhampton NHS Trust
    New Cross Hospital Wolverhampton Road Heath Town
    Wolverhampton
    WV10 0QP
  • Norfolk and Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Chelsea & Westminster Hospital
    369 Fulham Road
    London
    SW10 9NH
  • Burnley General Hospital
    Casterton Avenue
    Burnley
    BB10 2PQ
  • Bedfordshire Hospitals NHS Foundation Trust
    Lewsey Road
    Luton
    LU4 0DZ
  • Lincoln County Hospital
    Greetwell Road
    Lincoln
    LN2 5QY
  • Bolton Royal Hospital
    Minerva Road Farnworth
    Bolton
    BL4 0JR
  • Birmingham Heartlands Hospital
    Bordesley Green East Bordesley Green
    Birmingham
    B9 5SS
  • St Helier Hospital
    Wrythe Lane
    Carshalton
    SM5 1AA
  • Pinderfields General Hospital
    Aberford Road
    Wakefield
    WF1 4DG
  • Watford General Hospital
    60 Vicarage Road
    Watford
    WD18 0HB
  • Medway Maritime Hospital
    Windmill Road
    Gillingham
    ME7 5NY
  • Royal Oldham Hospital
    Rochdale Road
    Oldham
    OL1 2JH
  • Queens Medical Centre, Nottingham University Hospital
    Derby Road
    Nottingham
    NG7 2UH
  • Princess Royal Hospital
    Apley Castle, Grainger Drive Apley
    Telford
    TF1 6TF
  • Arrow Park Hospital
    Arrowe Park Road
    Wirral
    CH49 5PE
  • Queens Hospital
    Rom Valley Way
    Romford
    RM7 0AG
  • The Tunbridge Wells Hospital
    Tonbridge Road Pembury
    Tunbridge Wells
    TN2 4QJ

Use of verbal consent
As both interventions are already in routine clinical practice, the trial will use a verbal consent approach. This is designed to keep the study as simple as possible, make it easier for babies to take part and minimise the burden on parents. Acceptability by UK research ethics committees and parents of consent approaches that do not include a written consent form has been demonstrated, as well as feasibility in recent and ongoing neonatal trials (WHEAT Pilot, WHEAT International and neoGASTRIC trials). Parents in three focus groups conducted during the development of the BASE trial application indicated that consent models which do not include a written consent form would be their preferred method in the immediate period after preterm delivery. Parents will be provided with trial information by members of the clinical care team in the antenatal period or during neonatal admission prior to randomisation. Paper and electronic patient information sheets will be provided and trial information videos and animation will be available online. Parents of eligible babies will be approached by a member of the neonatal team. Parents will confirm if they are willing for their baby to participate in the study during a verbal conversation with site staff. It will be documented in the baby’s medical notes that information about the study has been provided to the parents and verbal consent has been obtained. A Verbal consent approach means that there will not be a signed consent form. Verbal consent will be documented in the baby's medical notes and Investigator Site File (ISF) and this will be checked before randomisation.
The majority of trial data will be obtained from routinely recorded clinical data held in the National Neonatal Research Database (NNRD), which will reduce the burden of data collection for participating sites. Babies will remain allocated to the same care pathway until they reach 40 weeks postmenstrual age or are discharged from neonatal care (whichever is sooner). No data collection is required by parents whilst their baby is in neonatal care. Final follow-up assessment by parent questionnaire will be conducted at 24 months of age corrected for prematurity. Neurodevelopmental outcomes at 24 months of age corrected for prematurity will be collected remotely via a parent questionnaire completed electronically using a bespoke secure online trial questionnaire. Alternative methods will be offered for those not wishing to complete online, i.e. on paper via a postal questionnaire or over the telephone with a member of the trial team. Parents will also be given the option of completing the questionnaire over the telephone via Language Line translation services where they do not read or speak English sufficiently enough to complete the questionnaire. A multi-language handout will be provided when contacting parents to inform them of the option to use translation services through the BASE coordinating centre.
Where possible, before discharge from the neonatal unit, a discussion will take place with parents to remind them about follow-up and that the trial team will contact them at 24 months of age corrected for prematurity for parent-reported outcome data. In the event that parents do not complete a 24-month questionnaire or if there is missing data, routine clinical data relating to the child’s 24-month clinical follow-up assessment will be requested from sites for assessment by the Blinded Endpoint Review Committee (BERC) to classify neurodevelopmental outcome.
Most babies who develop metabolic acidosis are likely to have a cannula as part of routine care. However, occasionally when a baby does not have a cannula, the placement of a cannula in order to administer sodium bicarbonate would be required. Parents will be informed in the Parent Information Leaflet (PIL) that this may happen if their baby is allocated to routine use of sodium bicarbonate infusion arm.

Miss Catherine Thompsett
base@npeu.ox.ac.uk


Dr Sabita Uthaya
s.uthaya@imperial.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Oxford and funded by Health Technology Assessment Programme.



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Read full details for Trial ID: ISRCTN18260410

Or CPMS: 56448

Last updated 07 March 2025

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