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Not yet recruitingNCT06342362Updated Apr 2, 2024

Magnesium Sulfate in Neonatal HIE"

A Phase 4 interventional study of Magnesium sulfate and placebo or standard treatment) in Neonates With HIE, sponsored by Sindh Institute of Child Health and Neonatology. Not yet recruiting at 1 site in Pakistan. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by Sindh Institute of Child Health and Neonatology · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
1 Day to 30 Days
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Neonates With HIE
03

In context

Lead sponsor

Sindh Institute of Child Health and Neonatology is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
1 Day to 30 Days
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • 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

  • 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)

Interventions

  • DrugMagnesium sulfate

    Participants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment).

  • Otherplacebo or standard treatment)

    placebo or standard treatment)

06

What researchers measure

Primary outcomes

  1. Neuroprotective effects

    Neuroprotective effects: decrease in the frequency or duration of seizures, ability to suck

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06342362
Lead sponsor
Sindh Institute of Child Health and Neonatology
Responsible party
Sher Wali Khan (fellow Neonatologist, Sindh Institute of Child Health and Neonatology) — Principal investigator
First posted
Apr 2, 2024
Start date
Apr 2, 2024 (estimated)
Primary completion
Oct 2, 2024 (estimated)
Completion
Dec 2, 2024 (estimated)
Last update
Apr 2, 2024

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 Mar 2024. You cannot join it, but the record below documents what was studied.

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