Continuous Glucose Monitoring and Preterm Infants

Completed · Phase 4

Conditions studied: Infant, Very Low Birth Weight, Neonatal Hypoglycemia

In brief

Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI). Glycemic monitoring is usually performed by capillary or central line sampling but does not identify up to 81% of hypoglycemic episodes in preterm newborns. The investigators aim to assess if a continuous glucose monitor (CGM) can be used to maintain euglycemia (defined as a target value 72-144mg/dl) in VLBWI. It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, within 48 hours of life, they will be randomized in two study arms, both them will wear Dexcom G4 Platinum CGM: 1) Unblinded group (UB): glucose daily intake will be modulated according to CGM (Dexcom G4 Platinum) during the first 7 days of life, alarms for hypos/hyper will be active; 2) Blinded group (B), glucose infusion rate will be modified according to 2-3 daily capillary glucose tests, alarms for hypos will be switched off. Pain at insertion will be evaluated with the validated Premature Infant Pain Profile (PIPP) scale. The estimated numerosity is 50 patients (25 for each arm).

Key facts

Study ID
NCT02583776
Run by
University Hospital Padova
People needed
50
Starts
2015-10-01
Expected to finish
2016-04-01
Last updated by the study team
2016-08-10

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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