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Not yet recruitingNCT07652801Updated Jun 17, 2026

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

A Phase 3 interventional study of MgSO4 (seizure prevention) and Melatonin , Mgso4 in HIE - Hypoxic - Ischemic Encephalopathy, sponsored by University of Child Health Sciences and Children's Hospital, Lahore. Not yet recruiting. Open to participants aged 1 Hour to 28 Days. Per ClinicalTrials.gov, last updated 2026-06-17.

Sponsored by University of Child Health Sciences and Children's Hospital, Lahore · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Hour to 28 Days
Sex
All
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Study 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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Conditions studied

  • HIE - Hypoxic - Ischemic Encephalopathy
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In context

Hypoxia-Ischemia, Brain

261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.

This study's planned enrollment of 80 is above the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.

Browse Hypoxia-Ischemia, Brain studies →

Lead sponsor

University of Child Health Sciences and Children's Hospital, Lahore is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Hour to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    melatonin along with Mgso4 infusion

    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

  • Active comparator
    Mgso4 alone

    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

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

  • DrugMelatonin , Mgso4

    Drug pages: Melatonin · Magnesium sulfate anhydrous

    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

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What researchers measure

Primary outcomes

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

    change in arterial PH,SERUM LDH

    Time frame: 5 DAYS

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — I do not plan to share raw participant data

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2026
First posted
Jun 17, 2026
StartEst.
Jul 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jun 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07652801
Lead sponsor
University of Child Health Sciences and Children's Hospital, Lahore
Responsible party
Akasha Rehman (DOCTOR, University of Child Health Sciences and Children's Hospital, Lahore) — Principal investigator
First posted
Jun 17, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 17, 2026

Study contacts

dr akasha rehman rehman, MD Pedatrics
Contact
akasharehman55@gmail.com
923041867246
alia ahmed, FCPS,MRCPCH,FRCPCH
Contact
alia_ahmad99@yahoo.com
923344081996

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Melatonin · Magnesium sulfate anhydrous

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