Continuous Glucose Monitoring in HIE

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 6
SponsorUniversity of Campania Luigi Vanvitelli

About this trial

The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration. To further examine the efficacy of using CGM the following secondary outcomes in the two groups were assessed: mean glucose values, glucose variability within individuals, percentage of time that glucose values are in hyperglycaemic or hypoglycaemic ranges.

Randomized controlled trial recruiting neonates (Birth weight \>1.8kg, Gestation\>36 weeks) with moderate or severe hypoxic ischemic encephalopathy (HIE) following perinatal asphyxia . Neonates will be randomly assigned (1:1) within 6 hours of birth to receive either the intervention with real-time CGM or standard care for 72 hours.

Eligibility criteria

Qualifiers

Birth weight >1.8kg

Gestation >35 weeks

Aged <6hours

Moderate or severe HIE following perinatal asphyxia

Disqualifiers

Major congenital malformations

Inborn errors of metabolism,

Congenital infections

Imminent death

Trial design

Treatments tested in this trial

  • Dexcom ONE+

Treatment groups

70 Participants
are divided into 2 treatment groups