Magnesium Sulfate in Neonatal HIE"

NCT ID: NCT06342362

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-02
• Study Completion Date: 2024-12-02

Brief 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.

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

Conditions

Neonates With HIE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Magnesium sulfate

Intervention Type: DRUG

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

the control group (receiving a placebo or standard treatment)

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

Group Type: PLACEBO_COMPARATOR

placebo or standard treatment)

Intervention Type: OTHER

placebo or standard treatment)

Interventions

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).

Intervention Type: DRUG

placebo or standard treatment)

placebo or standard treatment)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sindh Institute of Child Health and Neonatology

OTHER

Sponsor Role: lead

Responsible Party

Sher Wali Khan

fellow Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SICHN

Karachi, Sindh, Pakistan

Countries

Pakistan

Facility Contacts

Naseem Ahmed, FCPS

Role: primary

drnaseemkubar@gmail.com

03003145554

Other Identifiers

SICHN/IRB-001/2024

Identifier Type: -

Identifier Source: org_study_id