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

NCT07652801 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: UCHSLahore2026MYSELF
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIE - Hypoxic - Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 1.Change in PH 2.Serum LDH(U/L)

  change in arterial PH,SERUM LDH

  5 DAYS

Study Arms (2)

melatonin along with Mgso4 infusion

EXPERIMENTAL

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

Drug: Melatonin , Mgso4

Mgso4 alone

ACTIVE COMPARATOR

Three doses of MgSO4 infusion at the rate of 250mg/kg per day intravenous over 1 hour on days 0, 1, and 2

Drug: MgSO4 (seizure prevention)

Interventions

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

Mgso4 alone

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

melatonin along with Mgso4 infusion

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Child Health Sciences and Children's Hospital, Lahore: lead

MeSH Terms

Interventions

Melatonin; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

dr akasha rehman rehman, MD Pedatrics

CONTACT

923041867246; akasharehman55@gmail.com

alia ahmed, FCPS,MRCPCH,FRCPCH

CONTACT

923344081996; alia_ahmad99@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share