Hyperglycemia Clinical Trial
Official title:
Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia
Verified date | June 2024 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | August 30, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility | Inclusion Criteria: - preterm infants (gestational age (GA) at birth < 31 weeks) - admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit - written informed consent can be secured from a parent within 96 hours of birth. Exclusion Criteria: - Infants born at =31 weeks GA - infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development - children experiencing severe birth asphyxia, - children enrolled in another nutritional study, - children likely to be transferred out of the NICU |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of hypo- and hyperglycemia - CGM device | Proportion of CGM device readings that match blood glucose readings | 10 days post placement of CGM | |
Primary | Detection of hypo- and hyperglycemia - 60 mg/dL | % time below 60 mg/dL | 10 days post placement of CGM | |
Primary | Detection of hypo- and hyperglycemia - 180 mg/dL | % time above 180 mg/dL | 10 days post placement of CGM | |
Primary | Detection of hypo- and hyperglycemia - AEs | % of infants with adverse events secondary to CGM placement or wear | 10 days post placement of CGM |
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