Magnesium Sulfate in Neonatal HIE"

Neuroprotective Outcomes of Magnesium Sulfate in Neonates With Hypoxic-Ischemic Encephalopathy (HIE) at Tertiary Care Hospital of Karachi

The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonates With HIE
• Intervention / Treatment: Drug: Magnesium sulfate; Other: placebo or standard treatment)

Detailed Description

Objective:

• To determine the neuroprotective outcomes of intravenous magnesium sulphate in neonates with hypoxic ischemic encephalopathy (HIE) at a tertiary care hospital of Karachi.

Methodology:

• Study Setting: This is a prospective study; and will be conducted at tertiary care hospital of Karachi (Sindh Institute of Child Health and Neonatology, K-5).
• Study Design: Rndomized clinical Trial
• Target Population: The study population will be all term and near term newborns (≥35 completed weeks) with moderate to severe HIE.
• Inclusion Criteria: All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial.

• Exclusion Criteria:

  • Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded.
  • Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes.
  • Congenital anomalies or genetic disorders affecting neurological function.
  • Allergy or known adverse reactions to magnesium sulfate.
  • Participation in another concurrent clinical trial involving investigational drugs or interventions.
  • Inability to obtain informed consent from parents or guardians.
• Medical Intervention: Magnesium sulphate as infusion will be commenced to cases. Control will be treated as per unit protocol.

Sample Size:

Sample size was calculated using WHO software with the following assumptions:

Level of significance α=0.05 Power of study = 80 Anticipated population proportion P1 = 0.657 Anticipated population proportion P2 = 0.3757 Desired precision = 5 Required sample size 51 for each population (cases 51 and control 51) so, the total 102 is the minimum sample

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74201
      • SICHN
      • Contact: Naseem Ahmed, FCPS; Phone Number: 03003145554; Email: drnaseemkubar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: All Late preterm and term newborn with hypoxic ischemic encephalopathy (HIE) on basis of sarnat score and reaching in our unit within 6 hours of life will be the part of our trial.

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Exclusion Criteria:

• Newborns of less than 34 weeks, with dimorphism, comorbidities or arriving after 6 hours of birth, will be excluded.
• Pre-existing medical conditions that may interfere with the assessment of neuroprotective outcomes.
• Congenital anomalies or genetic disorders affecting neurological function.
• Allergy or known adverse reactions to magnesium sulfate.
• Participation in another concurrent clinical trial involving investigational drugs or interventions.
• Inability to obtain informed consent from parents or guardians.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group (receiving magnesium sulfate); Participants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment).	Drug: Magnesium sulfate; Participants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment).
Placebo Comparator: the control group (receiving a placebo or standard treatment); Participants would be randomly assigned to either the treatment group (receiving	Other: placebo or standard treatment); placebo or standard treatment)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroprotective effects	Neuroprotective effects: decrease in the frequency or duration of seizures, ability to suck	6 months

Collaborators and Investigators

• Sponsor: Sindh Institute of Child Health and Neonatology

Study record dates

Study Major Dates

• Study Start (Estimated): April 2, 2024
• Primary Completion (Estimated): October 2, 2024
• Study Completion (Estimated): December 2, 2024

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: SICHN/IRB-001/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No