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Continuous Glucose Monitoring and Preterm Infants (CGM&VLBWI)

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ClinicalTrials.gov Identifier: NCT02583776
Recruitment Status : Completed
First Posted : October 22, 2015
Last Update Posted : August 10, 2016
Sponsor:
Collaborators:
Boston Children’s Hospital
University of Padova
Information provided by (Responsible Party):
Alfonso Galderisi, University Hospital Padova

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Infant, Very Low Birth Weight Neonatal Hypoglycemia Device: Unblinded - CGM Device: Blinded - CGM Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: NEONATAL HYPOGLYCEMIA and CONTINUOUS GLUCOSE MONITORING: A RANDOMIZED CONTROLLED TRIAL IN PRETERM INFANTS
Study Start Date : October 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Unblinded CGM
CGM data will be "unblinded", with Hypo/hyperglycemia alarms on. Data will be recorded from CGM every three hours and intervention to adequate glucose intake will be performed to keep glycemia in normal range (72-144mg/dl) if necessary.
Device: Unblinded - CGM
Data from device will be readable and alarms on

Blinded CGM
Hypo/hyper alarms are off. CGM data will be blinded. Glucose intake will be adequate according to 2-3 capillary glycemic tests per day.
Device: Blinded - CGM
Data from device will be blinded and alarms off




Primary Outcome Measures :
  1. In range - time [ Time Frame: 7 days (minimum 2) ]
    Percentage of time in range 72-144mg/dl


Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 7days ]
    percentage of time below 40mg/dl

  2. Acute event associated to glycemic variability and/or hypoglycemia [ Time Frame: 7days ]
    Acute events (cerebral hemorrhage) and association with glycemic variability (specific patterns)

  3. Glycemic variability and hypoglycemia predictors [ Time Frame: 7days ]
    Evaluation of glycemic variability

  4. hypoglycemia prediction [ Time Frame: 7days ]
    Predictors of hypoglycemia: to individuate glycemic patterns/trends that could predict hypoglycemia

  5. Glycemic modeling [ Time Frame: 7days ]
    Creation of a glycemic modeling to predict hypoglycemia and to prevent it (see Klonoff DC et al J Diabetes Sci Technol. 2010)

  6. Pain associated to insertion of CGM respect to Pain associated to heel prick [ Time Frame: 7 days ]
    PIPP scale will be used to compare CGM vs heel prick in each subject. The scale consists of a numeric score as described by Stevens B (Clin J Pain, 1996)



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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (and/or):

  • <= 32 weeks gestation
  • birthweight <1500 g

Exclusion Criteria:

  • birthweight <500g
  • malformative syndrome
  • lack of parental consent
  • chromosomal abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583776


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, MA02215
Italy
Neonatal Intensive Care Unit - University Hospital of Padua
Padua, Italy, 35128
Department of Information Engineering - University of Padua
Padua, Italy, 35131
Sponsors and Collaborators
University Hospital Padova
Boston Children’s Hospital
University of Padova
Investigators
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Principal Investigator: Alfonso Galderisi, MD University Hospital of Padua
Principal Investigator: Daniele Trevisanuto, MD University Hospital of Padua

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alfonso Galderisi, MD, University Hospital Padova
ClinicalTrials.gov Identifier: NCT02583776     History of Changes
Other Study ID Numbers: 3440/AO/15
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by Alfonso Galderisi, University Hospital Padova:
continuous glucose monitoring (cgm)
neonatal hypoglycemia
very low birth weight infants (VLBWI)
preterm infants

Additional relevant MeSH terms:
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Hypoglycemia
Birth Weight
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms