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Reference:Lancet 2013 Dec 21;382(9910):2077 (level 1 [likely reliable] evidence)
Neonatal hypoglycemia is reported to occur in 5%-15% of otherwise healthy babies, and is considered a risk factor for brain injury or adverse neurodevelopmental outcomes. Many newborns with low blood glucose levels are separated from their mothers and admitted to the neonatal intensive care unit (NICU), where they receive intravenous dextrose. This separation may inhibit maternal bonding and disrupt the establishment of breastfeeding. The use of buccal dextrose gel in newborns with hypoglycemia was previously evaluated in a randomized trial that showed no significant difference in blood glucose concentrations compared to no treatment. However, this earlier trial did not evaluate patient-oriented outcomes. Now, a randomized trial compares buccal dextrose gel to placebo in newborns with hypoglycemia, and evaluates both glycemic outcomes and the need for admission to the NICU.
The study screened babies born at gestational age ≥ 35 weeks who were at risk of neonatal hypoglycemia. A total of 242 infants (gestational age 35-42 weeks) developed hypoglycemia, defined as blood or interstitial glucose level less than 2.6 mmol/L (46.8 mg/dL), and were randomized to receive dextrose 40% gel 200 mg/kg massaged into the buccal mucosa vs. placebo gel. Afterwards, infants were encouraged to feed. If feeding was poor, infants were given expressed breast milk or formula by syringe, according to maternal preference. Blood glucose levels were assessed at 30 minutes following the first treatment. If hypoglycemia persisted or recurred, infants received another dose, up to a maximum of 6 doses over 48 hours. Treatment failure was defined as blood glucose level < 2.6 mmol/L at 30 minutes following the second dose of study gel. Infants who met the criteria for treatment failure were admitted to the NICU and treated with open-label dextrose gel, infant formula, or intravenous dextrose, according to clinical guidelines and clinician preference.
Each group received a median of 2 doses of study gel. After excluding 5 infants who were randomized in error, 237 infants (98%) were included in a modified intention-to-treat analysis. The rate of admission to the NICU for hypoglycemia was 14% in the dextrose group compared to 25% in the placebo group (p = 0.03, NNT 10). The overall admission rate to the NICU was 38% with dextrose gel vs. 46% with placebo, but this difference was not statistically significant. Treatment failure occurred in 14% of infants receiving dextrose gel compared to 24% receiving placebo gel (p = 0.04, NNT 10). In addition, the need for other sources of dextrose (either open-label dextrose gel after treatment failure or intravenous dextrose) was 10% in the dextrose group compared to 24% in the placebo group (p = 0.01, NNT 8). There were no significant differences in the number of rebound or recurrent hypoglycemia episodes, and no serious adverse events occurred.
Many specialists agree that newborns with hypoglycemia and neurological symptoms should receive urgent treatment and glucose monitoring. In addition, several risk factors have been identified that might suggest increased neonatal risk, including maternal diabetes, obesity, and low birth weight. However, optimal management of neonatal hypoglycemia in other groups should find a proper balance between reducing the risk of long-term complications, while at the same time minimizing the effect of an abnormal screening result on neonatal adaptation and feeding. This new randomized trial shows that dextrose gel reduces admission to neonatal intensive care unit for hypoglycemia. In doing so, it minimizes the need for unnecessary interventions that separate newborns from their mothers. Furthermore, the gel is inexpensive and well tolerated.
For more information, see the Neonatal hypoglycemia topic in DynaMed.