Neonatal hypoglycaemia and hyperglycaemia are associated with brain injury and impaired
neurodevelopment outcomes in neonates with HIE. Improving early glucose control is an
important modifiable risk factor for outcomes in this population. Glycaemic monitoring is
usually performed by capillary or central line sampling. However, over 30% of the
episodes of abnormal glucose concentration are undetected, even with regular but
intermittent sampling. CGM can allow earlier detection and prevention of exposure to
extreme glucose concentrations.
Study design - This is a multicentre interventional, open-label, randomized controlled
trial of CGM compared with standard clinical management (control).A total of 70 neonates
(Birth weight >1.8kg, Gestation >36 weeks and aged <6hours) with moderate or severe HIE
following perinatal asphyxia will be recruited within 6 hours of birth after informed
parental consent. Neonates with major congenital malformations, inborn errors of
metabolism, congenital infections, imminent death will be excluded.
Neonates will be randomly assigned (1:1) to receive either the intervention with
real-time CGM for 72 hours or standard care using a randomization program (R package SRS:
A Subject Randomization System). We will use the minimization method to control for
severity and to achieve balance within recruiting centres. In all the neonates recruited
Dexcom ONE+ CGM (Dexcom, San Diego, CA, USA) will be placed soon after study enrollment.
The sensors will be inserted in the lateral thigh and continuous measurements will be
recorded for 72 h. The CGM device will be calibrated using blood glucose values measured
by point-of-care test. CGM calibrations will be performed at least twice a day. CGM data
will be downloaded by using Dexcom Studio software on a dedicated computer.
In the standard care group, the CGM device will collect glucose data continuously, but
the clinical team will be blinded to the data. These neonates will have their glucose
control monitored and managed according to standard clinical practice using
intermittently sampled blood glucose levels. In the intervention group the CGM data will
be used to support clinical management including blood glucose measurements and decision
making. Changes in glucose and insulin infusion will be based primarily on the real-time
CGM data but blood glucose concentrations will be checked in case of rapid changes in CGM
data.
Interventions to target glucose control will be guided by a protocol shared among the
participating hospitals. As part of the study protocol, all the neonates will receive a
continuous infusion of glucose 10% of 3-4 mg/kg/minute and total fluid intake starting at
50-60 ml/kg/day followed by titration depending on urine output, renal function, and
management of glucose infusion rates.