[Neonatal hypoglycemia: glucose gel efficacy in the treatment of early hypoglycemia in newborns with risk factors. Randomized clinical trial]. / Hipoglucemia neonatal: eficacia de la glucosa gel en el tratamiento de la hipoglucemia precoz en recién nacidos con factores de riesgo. Ensayo clínico aleatorizado.

Hypoglycemia is the most frequent metabolic disorder in newborns; the administration of 40% glu cose gel in the oral mucosa could be as effective in its correction as the administration of formula milk, not interfering with breastfeeding. OBJECTIVE: To evaluate the efficacy of 40% glucose gel com pared with formula milk in the treatment of early asymptomatic hypoglycemia in newborns with risk factors. PATIENTS AND METHOD: Randomized clinical trial, non-inferiority, conducted in a private hos pital. Newborns attended in rooming-in with the following risk factors were included: late preterm, large and small for gestational age at term, and children of diabetic mothers. In the presence of hy poglycemia, one group received 40% glucose gel (A) in the oral mucosa and another group received formula milk (B). Therapeutic failure was considered as persistence or repetition of hypoglycemia in the first 48h of life. RESULTS: 866 NBs with risk factors were registered over 36 month; 278 (32.1 %) presented hypoglycemia; 105 NBs in group A and 115 in group B completed the study. 75 (71 %) NBs in group A and 104 (90,4 %) in group B achieved hypoglycemia correction. After analyzing the trends obtained, it was decided to discontinue the study. CONCLUSIONS: The administration of 40% glucose gel was not equivalent to the administration of formula milk in the treatment of early asymptomatic hypoglycemia in newborns with risk factors.