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

NCT ID: NCT07305350

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-05-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypoxic Ischaemic Encephalopathy (HIE)

Keywords

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Hypoxic ischemic encephalopathy (HIE) Melatonin Randomized Control Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a Randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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.

Group Type EXPERIMENTAL

Melatonin

Intervention Type DRUG

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.

Group B

55 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

Group Type ACTIVE_COMPARATOR

intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover

Intervention Type COMBINATION_PRODUCT

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

Interventions

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Melatonin

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.

Intervention Type DRUG

intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Dr. Amina Cheema

Dr Amina Cheema

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Khalid Masood, MBBS, FCPS

Role: STUDY_CHAIR

Children Hospital and University of Child Health Sciences, Lahore

Locations

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Children Hospital and University of Child Health Sciences, Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 32156180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34271782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34120482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33155883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34513419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33074195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36009340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 40350214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37883841 (View on PubMed)

Chakkarapani E, de Vries LS, Ferriero DM, Gunn AJ. Neonatal encephalopathy and hypoxic-ischemic encephalopathy: the state of the art. Pediatr Res. 2025 Mar 24. doi: 10.1038/s41390-025-03986-2. Online ahead of print.

Reference Type BACKGROUND
PMID: 40128590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36164277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30108392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33601197 (View on PubMed)

Other Identifiers

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No/779/CH-UCHS

Identifier Type: -

Identifier Source: org_study_id