Trials Sponsors Conditions Drugs Pricing

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 , Mgso4Drug

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

Age1 Hour - 28 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Both genders
Born at term i.e \>37weeks gestation

Sponsors & Collaborators

University of Child Health Sciences and Children's Hospital, Lahore
Otherlead

MeSH Terms

Interventions

MelatoninMagnesium Sulfate

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsMagnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur Acids

Central Study Contacts

dr akasha rehman rehman, MD Pedatrics

CONTACT

923041867246 akasharehman55@gmail.com

alia ahmed, FCPS,MRCPCH,FRCPCH

CONTACT

923344081996

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

July 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2026

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

melatonin along with Mgso4 infusion

Mgso4 alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

melatonin along with Mgso4 infusion

Mgso4 alone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record