Oral dextrose gel for prevention of hypoglycemia in small for gestation age neonates A randomized controlled trial

The title of the study is oral dextrose gel for prevention of hypoglycemia in small for gestation age- A randomized controlled trial. The study will be an open label parallel group randomized control trial and will take place in the department of neonatology at government medical college, Chandigarh.

The aim of the study is to evaluate the efficacy of oral dextrose gel administration in reducing incidence of hypoglycemia and incidence of breastfeeding rate at 6week of age. We will enrol 88 neonates in each limb, fulfilling the following inclusion criteria- Small for gestation age (less than 10 centile) , Gestation at birth equal to more than 32wk, birth weight equal to or more than 1200 g and less than 2500g and full enteral feed by 2hour of age. Babies with major congenital malformation and skin infection will be excluded. After obtaining consent, eligible neonate will be enrolled and randomly assigned to dextrose gel or control group. Randomization will be done as soon as clinical care team decide baby to be on full feed. Computer generated random sequence with permuted block of various sizes will be generated and placed in serially opaque number. Neonates randomized to dextrose gel group will be administered 200mg/kg of oral dextrose gel. Enteral feeding will be initiated within one hour of birth. The first dose of dextrose gel will be administered within 1hour of birth and repeat dose will be given every 12 hours till 72 hour of age. Neonate randomized to control group will be given saline placebo. At the time of randomization, continuous glucose monitoring sensor will be inserted in both group for 72 hours of age. the data of cgm sensor will be extracted at end of 72 hours of age. The outcome of the study will be incidence of hypoglycemia will be monitored at 2hr, 6hr and then every 6hr for first 72 hours after birth by glucometer. Other outcome-  proportion of time spent in hypoglycemia and hyperglycemia by CGM. The need and duration of intravenous fluid from patient record .and exclusive breast feeding rate at discharge and at 6 week of age by interviewing the mother or telephonically.