Role of melatonin in management of hypoxic ischaemic encephalopathy in newborns: A randomized control trial.

OBJECTIVE: To find out the effect of melatonin as adjunct therapy on outcome of admitted newborns presenting with hypoxic ischaemic encephalopathy.

METHODS: This randomized controlled trial was conducted at King Edward Medical University, Lahore, Pakistan, from October 2016 to March 2017, and comprised newborns with gestational age of 34 weeks or higher who fulfilled the definition of hypoxic ischaemic encephalopathy and presented within 12 hours of birth. The severity of hypoxic ischaemic encephalopathy was assessed by Thompson score. The subjects were randomised into standard treatment group and intervention group which received melatonin 10mg orally via nasogastric tube at admission. Newborns were followed for 28 days to see the effect of melatonin in terms of survival rate. Data was analyzed using SPSS 20.

RESULTS: There were 80 newborns with overall mean gestational age of 36.81±1.7 weeks and mean birth weight of 2578.75±536 grams. Each of the two groups had 40(50%) subjects. In the intervention group, 35(87%) subjects and 26(65%) cases in the standard treatment group survived (p=0.03).

CONCLUSIONS: Administration of melatonin as an adjunct therapy in the management of newborns with hypoxic ischaemic encephalopathy led to improved survival rate.