Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342362
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Magnesium Sulfate in Neonatal HIE
Sponsor:
Sindh Institute of Child Health and Neonatology
Organization:
Sindh Institute of Child Health and Neonatology
Study Overview
Official Title:
Neuroprotective Outcomes of Magnesium Sulfate in Neonates With Hypoxic-Ischemic Encephalopathy HIE at Tertiary Care Hospital of Karachi
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 α005 Power of study 80 Anticipated population proportion P1 0657 Anticipated population proportion P2 03757 Desired precision 5 Required sample size 51 for each population cases 51 and control 51 so the total 102 is the minimum sample
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 α005 Power of study 80 Anticipated population proportion P1 0657 Anticipated population proportion P2 03757 Desired precision 5 Required sample size 51 for each population cases 51 and control 51 so the total 102 is the minimum sample
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None