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

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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.