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

Phase 4

• Conditions: Metabolic acidosis; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN18260410
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-06
• Last Update Posted: 4 March 2024
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3764

Inclusion Criteria

1. Babies born between 23+0 and 30+6 weeks+days of gestation inclusive
2. Postmenstrual age less than 34+0 weeks+days
3. 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
4. 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified