"Two year outcomes after dextrose gel prophylaxis for neonatal hypoglycaemia"

摘要 低血糖(低血糖浓度)是常见的，也是唯一容易预防的脑部原因 对新生儿的伤害。美国每年约有120万婴儿出生时有低血糖风险 并需要定期验血才能发现这个问题。如果确实发生低血糖，通常用 额外喂养，如有必要，进入新生儿重症监护病房(NICU)静脉注射 葡萄糖。进入NICU将母亲和婴儿分开，干扰乳房的建立- 喂食，而且价格昂贵。 将葡萄糖凝胶涂在婴儿的脸颊内，是一种简单、安全、廉价和有效的反转治疗方法 新生儿低血糖。一项有2129名婴儿参加的随机试验目前正在进行中，以确定 葡萄糖凝胶可以用来预防低血糖。有新生儿低血糖风险的婴儿被随机分配到 葡萄糖或安慰剂凝胶预防。主要结果是进入NICU。 如果凝胶在预防低血糖和入院NICU方面有效，它还可以防止脑损伤和 加强母乳喂养。然而，重要的是要确定这些影响，如果它们最终成为现实， 对以后的发展、健康和成长结果有任何有利的影响。同样重要的是要确保 使用凝胶预防是安全的，因为观察数据表明，出生后血糖迅速上升 可能与较差的发育结果有关。 这项申请是为了从试验中跟踪婴儿，以确定是否有任何好处或不良影响 两年的修正年龄。评估将包括神经状态的标准化测量， 发育状况、执行功能、视觉和视觉处理、身体大小、一般健康和 家庭环境。 大约30%的婴儿出生时就有低血糖的风险，因此可能有资格服用葡萄糖凝胶 如果证明是有效的，就采取预防措施。这项后续研究将提供长期疗效和 在引入临床实践之前，安全性将是必不可少的。

Abstract Hypoglycemia (low blood glucose concentration) is common, and the only readily preventable cause of brain damage in newborn babies. Approximately 1.2 million babies a year in the US are born at risk of hypoglycemia and require regular blood tests to detect this problem. If hypoglycemia does occur, it is usually treated with additional feeding, and if necessary admission to a newborn intensive care unit (NICU) for intravenous glucose. Admission to NICU separates mothers and babies, interfering with the establishment of breast- feeding, and is expensive. Dextrose gel, rubbed inside the baby's cheek, is a simple, safe, inexpensive and effective treatment to reverse neonatal hypoglycemia. A randomized trial of 2,129 babies is currently under way to determine whether dextrose gel can be used to prevent hypoglycemia. Babies at risk of neonatal hypoglycemia are randomized to dextrose or placebo gel prophylaxis. The primary outcome is admission to NICU. If gel is effective in preventing hypoglycemia and admission to NICU, it may also prevent brain damage and enhance breast-feeding. However, it is important to determine whether these effects, if they do eventuate, have any beneficial effects on later developmental, health and growth outcomes. It is also important to be sure that using gel for prevention is safe, in view of observational data that a rapid rise in blood glucose after birth may be associated with poorer developmental outcomes. This application is to follow up babies from the trial to determine if there are any benefits or adverse effects at two years' corrected age. Assessments will include standardized measures of neurological status, developmental status, executive function, vision and visual processing, physical size, general health, and family environment. Approximately 30% of babies are born at risk of hypoglycemia and hence may be eligible for dextrose gel prophylaxis if it proves effective. This follow-up study will provide crucial evidence of longer term efficacy and safety that will be essential before introduction into clinical practice.