CompletedNot Applicable

Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates

France48 participantsStarted 2008-12

Plain-language summary

Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by intermittent capillary blood glucose testing in detecting and managing hypoglycemia. The investigators calculated a number of 48 neonates to be randomized between 2 ways of glucose level monitoring for their 3 first days of life : either by RT-CGMS (CGM-group), or by intermittent capillary glucose testing (IGM-group) associated with a blind-CGMS to detect retrospectively missed hypoglycemia. The investigators' hypothesis is that in the CGM group number and duration of hypoglycemia will be lower.

Who can participate

Age range1 Hour – 24 Hours

SexALL

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Inclusion Criteria: * Very low birth weight (VLBW) preterm infants (birth weight under 1500g) who were admitted before 24 hours of life in the Department of Neonatology of the University Hospital of Tours Exclusion Criteria: * a serious congenital abnormality, * a skin condition that contraindicated continuous glucose monitoring, * a transfer toward another hospital during the first days of life * an absence of parental agreement.

What they're measuring

number of hypoglycemia episodes

Timeframe: at the end of the first 3 days of life

Trial details

NCT IDNCT01942239

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

View on ClinicalTrials.gov More Hypoglycemia trials