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

NCT ID: NCT06932354

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

CGM

masked continuous glucose monitoring

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Hypoxic ischaemic encephalopathy Informed parental consent

Exclusion Criteria

• Known significant congenital malformation

• Maximum Eligible Age: 2 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathryn Beardsall

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Beardsall

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cambridge University Addenbrookes Hospital Trust

Cambridge, cambridge, United Kingdom

Countries

United Kingdom

Other Identifiers

251956

Identifier Type: -

Identifier Source: org_study_id