Magnesium Sulfate in Neonatal HIE"

Sindh Institute of Child Health and Neonatology

Status and phase: Not yet enrolling; Phase 4

Conditions: Neonates With HIE

Treatments: Drug: Magnesium sulfate; Other: placebo or standard treatment)

Study type: Interventional

Funder types: Other

Identifiers

NCT06342362

SICHN/IRB-001/2024

Details and patient eligibility

About

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.

Full 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

Enrollment: 102 estimated patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

treatment group (receiving magnesium sulfate)

Experimental group

Description:

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

Treatment:

Drug: Magnesium sulfate

the control group (receiving a placebo or standard treatment)

Placebo Comparator group

Description:

Participants would be randomly assigned to either the treatment group (receiving

Treatment:

Other: placebo or standard treatment)