This site is optimised for modern browsers. For the best experience, please use Google Chrome, Mozilla Firefox, or Microsoft Edge.

21/536 Sodium bicarbonate in neonatal care

Contents

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What are the benefits and harms of sodium bicarbonate in prevention or treatment of metabolic acidosis in critically ill babies?

  1. Intervention: 1) No use of sodium bicarbonate, 2) Intravenous sodium bicarbonate infusion, dosing strategy to be defined and justified.
  2. Patient group: Critically ill babies of any gestational age admitted to neonatal units where the clinician is considering giving bicarbonate for prevention or treatment of metabolic acidosis - to be defined and justified. Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Neonatal units/critical care.
  4. Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  5. Important outcomes: Brain injury outcomes of intraventricular haemorrhage (grade 3 or 4) identifiable on cranial ultrasound or MRI; survival; two-year developmental outcomes; adverse events; use of other interventions. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise.
  6. Other outcomes: Length of neonatal unit/critical care and hospital stay; parent/carer acceptability; organ failure; impact on feeding.
  7. Minimum duration of follow-up: To be defined and justified by applicants. Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study

Rationale

Metabolic acidosis is a commonly encountered issue in the management of critically ill neonates and especially of preterm infants during the first days of life. Acidosis is unbalancing of the acid-base equilibrium within the body, a complex physiological principle underlying acid generation and excretion, which can have significant consequences.

Infusion of sodium bicarbonate to restore the acid/base balance has traditionally been used across different patient groups in treatment of acidosis, including in pre-term infants. Some go further and routinely infuse bicarbonate for all pre-term babies with a view to prevent acidosis development and or progression.

There is however a considerable lack of evidence on which this established practice is based and how best to manage these babies remains a topic of considerable debate within the neonatal community. Some argue that the acidosis that can be seen in very pre-term babies is a self-limiting manifestation of the immature renal system and others suggest that routinely giving and/or treating babies with bicarbonate may actually cause more harm than good.

A high-quality randomised trial is therefore needed to help answer this important uncertainty.

Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR INVOLVE guidance on co-producing research.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 1 December 2021. Applications will be considered by the HTA Funding Committee at its meeting in January 2022.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition. For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared. 

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk