Information for Clinicians

Background

Sodium bicarbonate is widely used in the management of metabolic acidosis in very preterm babies, despite lack of evidence-based research. It is believed to correct metabolic acidosis and so improve cardiac function. However, the use of sodium bicarbonate can lead to worsening of intracellular acidosis with consequent adverse outcomes. Clinical practice varies between and within neonatal units around the UK. This 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 when a very preterm baby has metabolic acidosis.

Trial design

BASE is a multicentre, pragmatic, open-label, two-arm, parallel-group, randomised controlled trial, with an internal pilot.

The BASE Trial aims to investigate whether managing metabolic acidosis with sodium bicarbonate or not impacts the health and development in the short and long term.

Babies will be in one of two groups:

• Routine use of sodium bicarbonate infusion for episodes of metabolic acidosis

or

• No routine use of sodium bicarbonate infusion for episodes of metabolic acidosis

We will then compare 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 2 years old to understand if there are any longer-term effects of giving sodium bicarbonate or not on development.

The trial aims to recruit 3764 from approximately 45 neonatal units across the UK.

Inclusion Criteria

• Babies born between 23⁺⁰ and 30⁺⁶ weeks^+days of gestation inclusive
• Postmenstrual age less than 34⁺⁰ weeks^+days
• Metabolic acidosis defined as blood pH less than 7.2 with pCO₂ that is low or normal for the clinical context and a low bicarbonate level
• The parent's verbal consent for the baby to participate in the trial has been documented in the baby's medical notes and Investigator Site File (ISF)

Exclusion Criteria

• Life-threatening condition, or significant congenital anomaly
• Inborn error of metabolism (known or under active investigation)
• 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
• Current episode of metabolic acidosis immediately follows cardiopulmonary resuscitation.