Abstract
BACKGROUND: One of the most important causes of neonatal deaths in developing nations is birth asphyxia. Though the probability of a complete recovery is very low, hypoxic-ischemic encephalopathy (HIE) associated with asphyxia can be managed with multiple treatment options. The study evaluated the efficacy of the addition of magnesium sulfate (MgSO(4)) to melatonin therapy in neonates with HIE. METHODOLOGY: A prospective, observational study was conducted in the department of neonatal intensive care, Pakistan Institute of Medical Sciences Hospital, Islamabad, Pakistan from October 2020 to March 2021. All neonates with an Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) score of less than five at five minutes, umbilical blood pH of less than 7.0, and moderate neonatal encephalopathy as detected on the modified Sarnat score which is a clinical tool used for the assessment of the severity of HIE were included in the study. Neonates with congenital abnormalities, intrauterine growth retardation, neonatal sepsis, and infants born to mothers with diabetes mellitus type 2 were excluded from the study. The infants were randomly assigned to either of the groups, i.e., i) group 1 included neonates who were administered at least three doses of magnesium sulfate (MgSO(4)) infusion in addition to melatonin, or ii) group 2 included neonates who were administered melatonin only. Blood samples of all neonates were evaluated and compared between the two groups. RESULTS: A total of 90 neonates with HIE were included in the study. There was a predominance of female neonates. The mean ages of babies in group 1 and group 2 were 37.2 ± 0.43 and 37.3 ± 0.59 weeks, respectively. The mean weight on the term was 2.88 ± 0.11 and 2.89 ± 0.10, respectively. The Apgar score at 5 mins in group 1 was 1.73 ± 0.81 while in group 2, 1.82 ± 0.94. It was found that there was a more significant improvement in pH after 3 days and after one week of treatment in group 1 as compared to group 2. The mean pH in babies after three days of intervention was 7.23 ± 0.03 in group 1 which was significantly better than group 2 (p<0.0001). After seven days, the mean normalized to 7.39 ± 0.04 in group 1 (p < 0.0001). It was found that in patients in group 1, the mortality was lower than in group 2 (p < 0.0001). CONCLUSION: HIE patients who were administered melatonin in combination with magnesium sulfate yielded better patient outcomes. Thus, it was concluded that the use of magnesium sulfate as dual therapy with melatonin improved patient outcomes for HIE. However, it is recommended that similar studies are conducted with a wider range of parameters, such as duration of hospital stay and assessment of the neurological outcomes of the patients.