NCT06932354

Metabolic Monitoring During Therapeutic Hypothermia (Cooling) for Hypoxic Ischaemic Encephalopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kathryn Beardsall · Academic / Other
• Sex: All
• Age: 2 Days
• Healthy volunteers: Not accepted

Summary

This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Detailed description

In the UK approximately 1200 babies per year undergo 'cooling' for the treatment of 'birth asphyxia' or hypoxic ischaemic encephalopathy (HIE). HIE not only impacts on brain metabolism but disturbs the normal metabolic balance in these babies who are at risk of hypoglycaemia and hyperglycaemia, which may exacerbate the effect of their primary brain injury. The clinical significance of hypoglycaemia is dependent on the availability of alternative fuels such as ketones and lactate. Clinical management of glucose control in these extremely ill babies is challenging because of infrequent blood glucose measurements and inability to measure alternative fuels. We have used continuous glucose monitoring (CGM) to help target glucose control in extremely preterm infants who require intensive care. CGM however has not been used in babies who are being cooled. This study aims to determine if CGM can be safely used in these babies, and to use this alongside innovative methods to measure alternative fuels to optimise care of these vulnerable babies.

Conditions

• Hypoxic-Ischemic Encephalopathy

Interventions

Type	Name	Description
DEVICE	CGM	masked continuous glucose monitoring

Timeline

• Start date: 2019-05-10
• Primary completion: 2022-12-01
• Completion: 2024-12-31
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: United Kingdom