Abstract：
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.
METHODS: 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.
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.
METHODS: 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.
摘要：
低血糖症是新生儿最常见的代谢紊乱;在口腔粘膜中施用40％glucose凝胶可以像施用配方奶一样有效地纠正它，不干扰母乳喂养。
目的：评价40%葡萄糖凝胶与配方奶比较治疗有危险因素新生儿早期无症状性低血糖的疗效。
方法：随机临床试验，非自卑，在一家私人hospital进行。纳入以下危险因素的新生儿：晚期早产，足月胎龄大和小，和糖尿病母亲的孩子。在有高血糖的情况下，一组在口腔粘膜中接受40%葡萄糖凝胶(A),另一组接受配方乳(B).治疗失败被认为是在生命的最初48小时内持续或反复出现低血糖。
结果：在36个月内登记了866个有危险因素的NBs；278个（32.1%）出现低血糖；A组105个NBs和B组115个NBs完成了研究。A组中75个（71％）NB和B组中104个（90，4％）达到低血糖校正。在分析了所获得的趋势之后，决定停止这项研究。
结论：在有危险因素的新生儿早期无症状性低血糖的治疗中，40%葡萄糖凝胶的给药不等同于配方奶的给药。
目的：评价40%葡萄糖凝胶与配方奶比较治疗有危险因素新生儿早期无症状性低血糖的疗效。
方法：随机临床试验，非自卑，在一家私人hospital进行。纳入以下危险因素的新生儿：晚期早产，足月胎龄大和小，和糖尿病母亲的孩子。在有高血糖的情况下，一组在口腔粘膜中接受40%葡萄糖凝胶(A),另一组接受配方乳(B).治疗失败被认为是在生命的最初48小时内持续或反复出现低血糖。
结果：在36个月内登记了866个有危险因素的NBs；278个（32.1%）出现低血糖；A组105个NBs和B组115个NBs完成了研究。A组中75个（71％）NB和B组中104个（90，4％）达到低血糖校正。在分析了所获得的趋势之后，决定停止这项研究。
结论：在有危险因素的新生儿早期无症状性低血糖的治疗中，40%葡萄糖凝胶的给药不等同于配方奶的给药。
