Status:
RECRUITING
Continuous Glucose Monitoring in At-Risk Newborns
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
DexCom, Inc.
Children's Miracle Network
Conditions:
Neonatal Hypoglycemia
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance. At-risk newborns (infants of diabetic moth...
Eligibility Criteria
Inclusion
- At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria:
- Infant of a diabetic mother (IDM, pre-existing or gestational diabetes)
- Large for gestational age (LGA, \>90th percentile \[sex-specific\])
- Small for gestational age (SGA, \<10th percentile \[sex-specific\])
- Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation)
- Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia)
Exclusion
- Birth weight \<2kg
- hypoxic-ischemic encephalopathy
- a contraindication to oral feeding
- abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact)
- chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally
- infants who are not expected to survive or who are in extremis
- additional risk of immunocompromise, including:
- Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection
- Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas
- Systemic sepsis, viral syndromes
- Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases
- Abdominal wall defects
Key Trial Info
Start Date :
August 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04386005
Start Date
August 9 2021
End Date
June 1 2026
Last Update
August 15 2025
Active Locations (1)
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1
Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033