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

K

Kathryn Beardsall

Status

Completed

Conditions

Hypoxic-Ischemic Encephalopathy

Treatments

Device: CGM

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

Under 2 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hypoxic ischaemic encephalopathy Informed parental consent

Exclusion criteria

  • Known significant congenital malformation

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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