Hypoglycemia Clinical Trial
Official title:
Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia
This will be a quasi-experimental study comparing blood glucose values 30 minutes after feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal hypoglycemia.
BACKGROUND: Low blood sugar in newborns affects about 10% of all deliveries and about 50% of
newborns with identified risk factors and is associated with poor long-term
neurodevelopmental outcomes. Risk factors for transient neonatal hypoglycemia include
infants of diabetic mothers, infants who are large or small for gestational age, infants
with intrauterine growth restriction, and late-preterm infants.
GAP: Current standard of care recommends asymptomatic infants to receive intravenous
dextrose after becoming hypoglycemic. International studies using dextrose gel have shown
that the buccal mucosa is a promising alternative route, normalizes hypoglycemia, and
decreases NICU admission. So far, no studies have published results about the efficacy of
prophylactic dextrose gel.
HYPOTHESIS: We hypothesize that the prophylactic treatment of newborns at-risk for transient
neonatal hypoglycemia with 40% dextrose gel will raise blood sugar levels by 15% compared to
untreated controls. We hypothesize that 40% dextrose gel will prevent up to 50% of NICU
admissions in this at-risk population compared to matched controls.
METHODS: This will be a quasi-experimental study. The study population will include babies
born at Harris Health Ben Taub Hospital and have risk factors for transient neonatal
hypoglycemia. After the baby completes its first feed, he or she will be given a dose of
oral dextrose gel. A blood sugar level will be checked after 30 minutes, per standard of
care. One hundred at-risk infants will be identified and have written parental consent prior
to delivery and receiving the prophylactic treatment. Five hundred additional matched
controls with similar risk factors will be analyzed for comparison and will not receive
treatment.
RESULTS: Pending
IMPACT: If the study proves the hypotheses are correct, prophylactic dextrose gel could be
implemented in newborn nurseries around the country to prevent transient hypoglycemia,
decrease NICU admission (and its associated costs, painful procedures, and separation from
family), improve feeding quality, and potentially optimize neurodevelopmental outcomes.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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