Neonates With HIEPhase 4NCT06342362
Magnesium Sulfate in Neonatal HIE"
A Phase 4 study testing Magnesium sulfate in people with Neonates With HIE, run by Sindh Institute of Child Health and Neonatology at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Neonates With HIE
- What is being tested?
- Magnesium sulfate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2024to 2 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
SICHN
Karachi, Sindh, 74201
Naseem Ahmed, FCPS, 03003145554, drnaseemkubar@gmail.com
About this study
Official title: 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.
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
- Conditions
- Neonates With HIE
- Being tested
- Magnesium sulfate, placebo or standard treatment)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Participants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment).
placebo or standard treatment)Other
placebo or standard treatment)
| Study group | Role | What they receive |
|---|---|---|
| treatment group (receiving magnesium sulfate) | Experimental | Participants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment). Receives: Drug: Magnesium sulfate |
| the control group (receiving a placebo or standard treatment) | Placebo comparator | Participants would be randomly assigned to either the treatment group (receiving Receives: Other: placebo or standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroprotective effects
Neuroprotective effects: decrease in the frequency or duration of seizures, ability to suck
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start2 Apr 2024 (estimated)
- Primary completion2 Oct 2024 (estimated)
- Study completion2 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates With HIEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Child Health and Neonatology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sher Wali Khan, Sindh Institute of Child Health and Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342362
- Sponsor's protocol ID
- SICHN/IRB-001/2024
- Status last verified
- Mar 2024
- First submitted
- 26 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Outcomes of Magnesium Sulfate in Neonates With Hypoxic-Ischemic Encephalopathy (HIE) at Tertiary Care Hospital of Karachi
- ClinicalTrials.gov ID
- NCT06342362
- Acronym / sponsor ID
- SICHN/IRB-001/2024
- Conditions
- Neonates With HIE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Sindh Institute of Child Health and NeonatologyUniversity, hospital or other
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 2 Oct 2024 (estimated)
- Study completion
- 2 Dec 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group (receiving magnesium sulfate) | Experimental | Drug: Magnesium sulfateParticipants 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) | Placebo comparator | Other: placebo or standard treatment)Participants would be randomly assigned to either the treatment group (receiving |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateParticipants would be randomly assigned to either the treatment group (receiving magnesium sulfate) or the control group (receiving a placebo or standard treatment). | Drug | treatment group (receiving magnesium sulfate) |
| placebo or standard treatment)placebo or standard treatment) | Other | the control group (receiving a placebo or standard treatment) |
Primary outcome
Neuroprotective effects
Time frame: 6 months
Neuroprotective effects: decrease in the frequency or duration of seizures, ability to suck
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate in people with Neonates With HIE, run by Sindh Institute of Child Health and Neonatology at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroprotective effects (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.