COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE

NCT07652801 — Phase 3, Not yet recruiting, 80 participants, University of Child Health Sciences and Children's Hospital, Lahore

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COMPARISON OF OUTCOME OF HYPOXIC ENCEPHLOPATHY MANAGED WITH MgSO4 AND MELATONIN VERSUS MgSO4 ALONE

Registry	NCT07652801
Status	Not yet recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	80 (Estimated)
Sponsor	University of Child Health Sciences and Children's Hospital, Lahore (Other)
Conditions	HIE - Hypoxic - Ischemic Encephalopathy
Interventions	MgSO4 (seizure prevention), Melatonin , Mgso4 (Drug)
Dates	start 2026-07-01 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-06-17, last updated 2026-06-17

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
melatonin along with Mgso4 infusion	Experimental	Drug: Melatonin , Mgso4	five doses of melatonin (10mg/kg daily enteral for 5days) 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
Mgso4 alone	Active comparator	Drug: MgSO4 (seizure prevention)	Three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2

MgSO4 (seizure prevention) (Drug): Three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2
Melatonin , Mgso4 (Drug): Five 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

+Outcome measures

Primary outcomes

1.Change in PH 2.Serum LDH(U/L) [5 DAYS]: change in arterial PH,SERUM LDH

+Eligibility

Sex: All, ages: 1 Hour to 28 Days

Inclusion Criteria:

* 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
* Evidence of atleast moderate grade ofHIE on sarnat scoring.

Exclusion Criteria:

* With congenital anamolies
* Intrauterine growth retadation
* suspicion of neonatal sepsis
* Congenital heart disese and those with IEM.