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Continuous Glucose Monitoring in HIE

ConditionsHypoxic Ischemic Encephalopathy of NewbornHyperglycemiaHypoglycemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Dexcom ONE+

    Device

    In all the neonates recruited CGM sensor and transmitter will be placed soon after study enrollment. The sensors will be inserted in the lateral thigh and continuous measurements will be recorded for all the duration of therapeutic hypothermia.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Experimental: Unblinded CGMExperimental treatment 1 intervention
Group B: Blinded CGMOther 1 intervention

Trial outcomes

Primary outcomes

1

In range - time

Proportion of time that the sensor glucose values are in the target range (50 to 180 mg/dL) compared between the study groups

Time frame
72 hours after birth

Secondary outcomes

1

Hypoglycemia

Percentage of time below 50 mg/dl

Time frame
72 hours after birth
2

Hyperglycemia

Percentage of time above 180 mg/dl

Time frame
72 hours after birth
3

Glycemic variability

Evaluation of glycemic variability

Time frame
72 hours after birth
4

Adverse events associated to insertion of CGM

% of infants with adverse events secondary to CGM placement or wear

Time frame
up to 10 days after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Campania Luigi Vanvitelli

Lead sponsor

Source ClinicalTrials.gov
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