HIE - Hypoxic - Ischemic EncephalopathyPhase 3NCT07652801
COMPARISON OF OUTCOME OF HYPOXIC ISCHEMIC ENCEPHLOPATHY MANAGED WITH COMBINATION OF MAGNESIUM SULPHATE AND MELATONIN VERSUS MAGNESIUM SULPHATE ALONE
A Phase 3 study testing MgSO4 (seizure prevention) and Melatonin , Mgso4 in people with HIE - Hypoxic - Ischemic Encephalopathy, run by University of Child Health Sciences and Children's Hospital, Lahore.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- HIE - Hypoxic - Ischemic Encephalopathy
- What is being tested?
- MgSO4 (seizure prevention) and Melatonin , Mgso4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- With congenital anamolies
- Intrauterine growth retadation
- suspicion of neonatal sepsis
- Congenital heart disese and those with IEM.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COMPARISON OF OUTCOME OF HYPOXIC ENCEPHLOPATHY MANAGED WITH MgSO4 AND MELATONIN VERSUS MgSO4 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.
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy
- Being tested
- MgSO4 (seizure prevention), Melatonin , Mgso4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 , 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: MgSO4 (seizure prevention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Change in PH 2.Serum LDH(U/L)
change in arterial PH,SERUM LDH
Measured: 5 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIE - Hypoxic - Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akasha Rehman, University of Child Health Sciences and Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652801
- Sponsor's protocol ID
- UCHSLahore2026
- Other IDs
- MYSELF
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not plan to share raw participant data
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF OUTCOME OF HYPOXIC ENCEPHLOPATHY MANAGED WITH MgSO4 AND MELATONIN VERSUS MgSO4 ALONE
- ClinicalTrials.gov ID
- NCT07652801
- Acronym / sponsor ID
- UCHSLahore2026
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin along with Mgso4 infusion | Experimental | Drug: Melatonin , Mgso4five 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 |
| Mgso4 alone | Active comparator | 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 |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- With congenital anamolies
- Intrauterine growth retadation
- suspicion of neonatal sepsis
- Congenital heart disese and those with IEM.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Mgso4 alone |
| Melatonin , Mgso4Five 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 | Drug | melatonin along with Mgso4 infusion |
Primary outcome
1.Change in PH 2.Serum LDH(U/L)
Time frame: 5 DAYS
change in arterial PH,SERUM LDH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. I do not plan to share raw participant data
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
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Neuro-MoD: Neuroplasticity With Motor Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MgSO4 (seizure prevention) and Melatonin , Mgso4 in people with HIE - Hypoxic - Ischemic Encephalopathy, run by University of Child Health Sciences and Children's Hospital, Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact dr akasha rehman rehman, MD Pedatrics (923041867246, akasharehman55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Change in PH 2.Serum LDH(U/L) (time frame: 5 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.