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Hypoxic Ischaemic Encephalopathy (HIE)Phase 2NCT07305350

EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES

A Phase 2 study testing Melatonin and intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover in people with Hypoxic Ischaemic Encephalopathy (HIE), run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy. Read more about this study

Who is it for?
Ages 1 hour and older
Conditions the study is for
Hypoxic Ischaemic Encephalopathy (HIE)
What is being tested?
Melatonin and intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 sitePakistan
Study dates
10 Dec 2025to 10 May 2026
Phase
Phase 2
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 and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All term infants (as per operational definition). Both genders. Presenting with hypoxic ischemic encephalopathy (as per operational definition).

Who cannot join

  • Drug reactions. Newborns at gestational age < 36 weeks. Neonates whose mother received general anesthesia. Neonates with congenital malformations. Neonates whose mother received anticonvulsants. Neonates not fulfilling criteria for HIE. Neonatal sepsis, pneumonia or in-born error of metabolism.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Children Hospital and University of Child Health Sciences, Lahore

    Lahore, Punjab Province, 05411

Other trials in Pakistan

About this study

To compare the survival rate and improvement in stage of hypoxic ischemic encephalopathy (HIE) at day 7 of treatment in neonates treated with versus without melatonin in addition to standard supportive therapy.

Read the detailed description

This is a randomized control trial and the purpose of this study is to determine efficacy of melatonin in management of hypoxic ischemic encephalopathy in newborns. Baseline characteristics will be documented after which patients will be divided into two groups by paper lottery method namely group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy and group B in which patients will be given standard supportive therapy only.

Being tested
Melatonin, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover
Keywords
Hypoxic ischemic encephalopathy (HIE), Melatonin, Randomized Control Trial
Medical subject headings
Hypoxia-Ischemia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelatoninDrug

    55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.

  • intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic coverCombination product

    55 neonates will be assigned group B in which patients will be given standard supportive therapy only.

Study groups in NCT07305350
Study groupRoleWhat they receive
Group AExperimental55 neonates will be assigned group A in which newborns will be given single 10mg dose of melatonin through nasogastric tube in addition to standard supportive therapy.
Receives: Drug: Melatonin
Group BActive comparator55 neonates will be assigned group B in which patients will be given standard supportive therapy only. Standard supportive therapy included oxygen therapy, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover for possible role of infection
Receives: Combination Product: intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonate survival rate

    Role of melatonin will be determined primarily by survival rate in neonates with hypoxic ischemic encephalopathy at 28 days of life.

    Measured: 28 days of life

Secondary outcomes (1)

  1. Improvement in stage of HIE

    Secondary outcome measures to determine role will be improvement in stage of hypoxic ischemic encephalopathy (based on Thomson score) at day 1, 3 and 7.

    Measured: Day 1, 3 and 7 of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start10 Dec 2025
  3. Primary completion10 May 2026 (estimated)
  4. Study completion10 May 2026 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
It is a Randomized control trial
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07305350
Sponsor's protocol ID
No/779/CH-UCHS
Status last verified
Dec 2025
First submitted
12 Dec 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to confidentiality

Publications

  • Siddiqui MA, Butt TK. Role of Intravenous Magnesium Sulphate in Term Neonates with Hypoxic Ischemic Encephalopathy (HIE) in a Low-income Country: A Randomised Clinical Trial. J Coll Physicians Surg Pak. 2021 Jul;31(7):817-820. doi: 10.29271/jcpsp.2021.07.817.

    PubMed 34271782

  • Ran Y, Ye L, Ding Z, Gao F, Yang S, Fang B, Liu Z, Xi J. Melatonin Protects Against Ischemic Brain Injury by Modulating PI3K/AKT Signaling Pathway via Suppression of PTEN Activity. ASN Neuro. 2021 Jan-Dec;13:17590914211022888. doi: 10.1177/17590914211022888.

    PubMed 34120482

  • Packer CH, Hersh AR, Sargent JA, Caughey AB. Therapeutic hypothermia in severe hypoxic-ischemic encephalopathy: a cost-effectiveness analysis. J Matern Fetal Neonatal Med. 2022 Mar;35(5):890-897. doi: 10.1080/14767058.2020.1733519. Epub 2020 Mar 10.

    PubMed 32156180

  • Michniewicz B, Al Saad SR, Karbowski LM, Gadzinowski J, Szymankiewicz M, Szpecht D. Organ Complications of Infants with Hypoxic Ischemic Encephalopathy Before Therapeutic Hypothermia. Ther Hypothermia Temp Manag. 2021 Mar;11(1):58-63. doi: 10.1089/ther.2020.0035. Epub 2020 Nov 5.

    PubMed 33155883

  • Iqbal N, Younus J, Malik M, Fatima B, Imran A, Maqbool S, Irfan Waheed KA, Haque K. The Neuroprotective Efficacy of Postnatal Magnesium Sulfate in Term or Near-Term Infants With Moderate-to-Severe Birth Asphyxia. Cureus. 2021 Aug 2;13(8):e16826. doi: 10.7759/cureus.16826. eCollection 2021 Aug.

    PubMed 34513419

  • Go H, Saito Y, Maeda H, Maeda R, Yaginuma K, Ogasawara K, Kashiwabara N, Kawasaki Y, Hosoya M. Serum cytokine profiling in neonates with hypoxic ischemic encephalopathy. J Neonatal Perinatal Med. 2021;14(2):177-182. doi: 10.3233/NPM-200431.

    PubMed 33074195

  • Florido J, Rodriguez-Santana C, Martinez-Ruiz L, Lopez-Rodriguez A, Acuna-Castroviejo D, Rusanova I, Escames G. Understanding the Mechanism of Action of Melatonin, Which Induces ROS Production in Cancer Cells. Antioxidants (Basel). 2022 Aug 20;11(8):1621. doi: 10.3390/antiox11081621.

    PubMed 36009340

  • Dolan F, Wintermark P. Updates in Treatment of Hypoxic-Ischemic Encephalopathy. Clin Perinatol. 2025 Jun;52(2):321-343. doi: 10.1016/j.clp.2025.02.010. Epub 2025 Mar 21.

    PubMed 40350214

  • Cornet MC, Kuzniewicz M, Scheffler A, Forquer H, Hamilton E, Newman TB, Wu YW. Perinatal Hypoxic-Ischemic Encephalopathy: Incidence Over Time Within a Modern US Birth Cohort. Pediatr Neurol. 2023 Dec;149:145-150. doi: 10.1016/j.pediatrneurol.2023.08.037. Epub 2023 Aug 31.

    PubMed 37883841

  • Chakkarapani E, de Vries LS, Ferriero DM, Gunn AJ. Neonatal encephalopathy and hypoxic-ischemic encephalopathy: the state of the art. Pediatr Res. 2025 Dec;98(7):2444-2458. doi: 10.1038/s41390-025-03986-2. Epub 2025 Mar 24.

    PubMed 40128590

  • Bobba PS, Malhotra A, Sheth KN, Taylor SN, Ment LR, Payabvash S. Brain injury patterns in hypoxic ischemic encephalopathy of term neonates. J Neuroimaging. 2023 Jan;33(1):79-84. doi: 10.1111/jon.13052. Epub 2022 Sep 26.

    PubMed 36164277

  • Ahmad QM, Chishti AL, Waseem N. Role of melatonin in management of hypoxic ischaemic encephalopathy in newborns: A randomized control trial. J Pak Med Assoc. 2018 Aug;68(8):1233-1237.

    PubMed 30108392

  • Ahmed J, Pullattayil S AK, Robertson NJ, More K. Melatonin for neuroprotection in neonatal encephalopathy: A systematic review & meta-analysis of clinical trials. Eur J Paediatr Neurol. 2021 Mar;31:38-45. doi: 10.1016/j.ejpn.2021.02.003. Epub 2021 Feb 11.

    PubMed 33601197

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Melatonin and intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover in people with Hypoxic Ischaemic Encephalopathy (HIE), run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.

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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonate survival rate (time frame: 28 days of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07305350, which also lists 13 linked publications.

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 26 Dec 2025.

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