About this trial
COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHALOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE Participants of group A will have 3 doses of MgSO4 infusion at rate of 250mg/kg per day intravenous over 1hour on day 0,1,2 Participants of group B will have 5 doses of Melatonin 10mg/kg for 5days along with MgSO4. They will undergo reassessment of arterial PH and serum LDH after completion of therapy. They will be followed for length of hospital stay and time until feed is initiated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Both genders
Born at term i.e >37weeks gestation
With APGAR score<5 at 1min
Umblical artery acidemia(PH<7 or base deficit>12mmol/L
Disqualifiers
With congenital anamolies
Intrauterine growth retadation
suspicion of neonatal sepsis
Congenital heart disese and those with IEM.
Trial design
Parallel
Treatments tested in this trial
MgSO4 (seizure prevention)
DrugThree doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2
Melatonin , Mgso4
DrugFive doses of melatonin along with three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2
Treatment groups
Trial outcomes
Primary outcomes
1.Change in PH 2.Serum LDH(U/L)
change in arterial PH,SERUM LDH
Locations
Sponsors and contacts
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