The Sugar Babies Study

None listed

Background Hypoglycaemia (low blood sugar) is the only common preventable cause of brain damage in babies. It is most common in the first twenty-four hours after birth, and is a common reason for admission to the Newborn Intensive Care Unit. Oral carbohydrate (sugar) is the first line of treatment of the conscious hypoglycaemic diabetic patient. However, oral treatment in babies has not been investigated. Waikato Hospital is the only hospital in Australasia to use 40% dextrose gel for treatment in babies. However, there is no evidence to support this practice. Furthermore, blood glucose levels are routinely measured intermittently. However blood glucose levels are known to fluctuate following birth and therefore periods of hypoglycaemia may be missed. We have developed experience with continuous glucose monitoring in the newborn. Hypothesis That 40% dextrose gel is more effective than feeding alone in reversing neonatal hypoglycaemia. That intermittent blood glucose monitoring does not detect all episodes of hypoglycaemia. Trial design We propose a randomised, placebo controlled, double-blinded study in hypoglycaemic babies = 35 weeks gestation, comparing the incidence of treatment failure in babies randomised to receive either dextrose gel 40% or a placebo vehicle gel. Method Where possible babies = 35 weeks gestation who are at risk of hypoglycaemia will be enrolled prior to birth. Following birth a continuous glucose monitor will be applied, and remain in place for 48 hours. If during routine clinical blood tests hypoglycaemia is diagnosed, babies will be fed, and in addition will be randomised to receive either 40% dextrose gel or a placebo vehicle gel. The baby will receive up to two doses of gel 30 minutes apart. If hypoglycaemia persists, the baby will be admitted to the Newborn Intensive Care Unit for on-going care. Outcomes The primary outcome is treatment failure, defined as a blood glucose level < 2.6mM 30 minutes after the second of two treatment attempts. Secondary outcomes include: time taken to achieve an interstitial glucose level >2.6mM for >1 hour; incidence of recurrent hypoglycaemia after an initial successful treatment; admission to the neonatal intensive care unit; frequency and total volume of formula administered in the first 48 hours; rate of full breast feeding at two weeks of age Significance and expected benefits Hypoglycaemia is very common in the newborn period. It is the most common cause of preventable brain damage in the newborn period. The diagnosis and management remain controversial. The majority of babies are admitted to the Newborn Intensive Care Unit for treatment. We hope to determine the effectiveness of an oral carbohydrate treatment regime that will reverse hypoglycaemia and allow the mother and baby to remain together. This may result in improving the rate of breast feeding and decrease hospital costs. In addition we aim to determine whether our current regime for intermittent blood glucose monitoring can be improved.