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

Phase III Interventional HIE - Hypoxic - Ischemic Encephalopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MgSO4 (seizure prevention), Melatonin , Mgso4.
Who it may be relevant to
Registry conditions: HIE - Hypoxic - Ischemic Encephalopathy. Basic parameters: 1 Hour — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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
  • Drug Melatonin , Mgso4
    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

Primary outcome measures

  • 1.Change in PH 2.Serum LDH(U/L) [Time frame: 5 DAYS]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07652801 · UCHSLahore2026 · MYSELF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗