- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499393
Hypothermia Enhanced by Magnesium Sulphate (Hemen)
Comparison of Two Method of Therapeutic Hypothermia Enhanced by Magnesium Sulphate in Neonatal Encephalopathy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
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Lodz, Poland, 93-338
- Polish Mother Memorial Hospital - Research Instutiute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Group A Infants > 36.0 weeks gestation* with at least ONE of the following: * for gestational age also use clinical assessment
- Apgar score of less than or equal to ≤5 at 10 (ten) minutes after birth
- continued need for resuscitation, including endotracheal or mask ventilation, at 10min after birth
- acidosis defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 min of birth less than (<) pH 7.00
- base deficit greater than or equal to (≥) 16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
Group B Newborn with moderate or severe encephalopathy with varying states of consciousness: lethargy, stupor, or coma and
One or more of below:
- hypotonia
- abnormal reflexes : oculomotor / pupillary
- suck: weak / absent
- clinical seizures - clinically confirmed
Group C integrated electroencephalogram (aEEG / CFM) (lasting at least 20 minutes), which indicates either a moderate / serious abnormalities in the background activity aEEG (a score of 2 or 3) or convulsions attacks.
Exclusion Criteria:
- major congenital maformation
- extremely poor prognosis : Apgar score 0 @ 15 minutes of life
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TH+MgSO4
Therapeutic hypothermia plus magnesium sulphate intravenous infusion Neonates who were randomized to the study group (TH+MgSO4) received three 250 mg/kg doses of magnesium sulfate given as one - hour continuous infusion spaced 24 hours apart on three consecutive days.
20% Magnesium Sulfuricum (Polpharma), 2 g /10 ml were used.
|
intravenous infusion of magnesium sulphate
Other Names:
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No Intervention: TH- therapeutic hypothermia
therapeutic hypothermia without magnesium sulphate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death
Time Frame: until discharge (participants will be followed for the duration of hospital stay @ hypothermia center, an expected up to 4 weeks
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until discharge (participants will be followed for the duration of hospital stay @ hypothermia center, an expected up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological status
Time Frame: 1-7 DOL
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according to Thompson scale (Hypoxic-ischemic encephalopathy score)
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1-7 DOL
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Neurological status
Time Frame: 24 months
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the long-term evaluation of psychomotor development according to the scale BAYLEY III
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24 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ewa Gulczynska, MD PhD, Polish Mother Memorial Hospital Research Instutute
Publications and helpful links
General Publications
- Merchant N, Azzopardi D. Early predictors of outcome in infants treated with hypothermia for hypoxic-ischaemic encephalopathy. Dev Med Child Neurol. 2015 Apr;57 Suppl 3:8-16. doi: 10.1111/dmcn.12726.
- Gulczynska EM, Gadzinowski J, Kesiak M, Sobolewska B, Caputa J, Maczko A, Walas W, Cedrowska-Adamus W, Talar T. Therapeutic hypothermia in asphyxiated newborns: selective head cooling vs. whole body cooling - comparison of short term outcomes. Ginekol Pol. 2019;90(7):403-410. doi: 10.5603/GP.2019.0069.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Body Temperature Changes
- Brain Injuries
- Hypothermia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- PolishMMHRI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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