Status: Funded - Open
Dextrose gel for newborn hypoglycemia
Sarah Coors, BSN, DO, FAAP
BACKGROUND: Prolonged and severe low glucose levels in newborns may lead to poor long-term neurodevelopmental outcomes. Low blood sugar in newborns affects about 10% of all deliveries and about 50% of newborns with identified risk factors.
GAP: Current standard of care recommends asymptomatic infants with low glucose levels to receive IV dextrose. International studies have shown that the buccal mucosa is a promising alternative route for the resolution of hypoglycemia.
HYPOTHESIS: We hypothesize that the treatment of newborn hypoglycemia with 40% dextrose gel will be more effective than placebo in hypoglycemic newborns. We hypothesize that 40% dextrose gel will permit more hypoglycemic infants to become normoglycemic and prevent up to 50% of NICU admissions.
METHODS: This will be a randomized, placebo-controlled double-blinded study. The study population will include newborns born at a gestational age of ≥35 weeks, <48 hours of life, have parental written informed consent, glucose value <45 mg/dL, and be admitted to the Newborn Nursery, Pavilion for Women NICU, or West Tower NICUs at Texas Children’s Hospital. Five hundred at-risk infants will be identified prior to delivery, anticipating half of them will become hypoglycemic, which will provide adequate power to evaluate the primary outcome.
IMPACT: If the study proves the hypotheses are correct, the next step would be a larger, multi-center trial with a larger sample size to confirm the findings which could change the current standard of care for the management of newborn hypoglycemia in the U.S., which is invasive, expensive, and often delayed, into a rapid, inexpensive, and readily-available treatment to be applied in a variety of clinical settings, including low-resource areas.