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

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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Key information

Conditions

HIE - Hypoxic - Ischemic Encephalopathy

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

1.Change in PH 2.Serum LDH(U/L)

Time frame: 5 DAYS

change in arterial PH,SERUM LDH

Study contacts

Contact information is provided by the study sponsor or research team.

alia ahmed, FCPS,MRCPCH,FRCPCH

CONTACT

[email protected]

923344081996

dr akasha rehman rehman, MD Pedatrics

CONTACT

[email protected]

923041867246

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 17, 2026
Registry last updated: Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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