Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy (MagCool)
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| ClinicalTrials.gov Identifier: NCT01646619 |
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Recruitment Status : Unknown
Verified April 2013 by Sajjad Rahman, Hamad Medical Corporation.
Recruitment status was: Recruiting
First Posted : July 20, 2012
Last Update Posted : April 4, 2013
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Sponsor:
Sajjad Rahman
Information provided by (Responsible Party):
Sajjad Rahman, Hamad Medical Corporation
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Brief Summary:
The purpose of this study is to assess whether the addition of a drug such as Magnesium sulphate while providing therapeutic hypothermia (or cooling) to babies who are asphyxiated at birth provides additional benefit to the babies' survival and outcome compared to cooling alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Severe Hypoxic Ischemic Encephalopathy Moderate Hypoxic Ischemic Encephalopathy | Drug: Magnesium Sulphate Drug: Placebo | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Multicenter Randomized Controlled Trial of Therapeutic Hypothermia Plus Magnesium Sulphate (MgSO4) Versus Therapeutic Hypothermia Plus Placebo in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy |
| Study Start Date : | May 2012 |
| Estimated Primary Completion Date : | December 2013 |
| Estimated Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Hypothermia + Magnesium Sulphate |
Drug: Magnesium Sulphate
10% MgSo4 (100mg/ml) given in a dose of 250mg/kg IV q 24 hrly for 3 doses(2.5ml/kg). Diluent: Dextrose 5%. Other Name: MgSo4 |
| Placebo Comparator: Hypothermia+ Placebo |
Drug: Placebo
Normal Saline 0.9% Sodium Chloride is diluted in 5% Dextrose to be given as 2.5ml/kg IV q24 hrly for 3 doses.
Other Names:
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Primary Outcome Measures :
- Combined outcome of Mortality and Severe Neurodevelopmental Disability [ Time Frame: 18 - 24 months of age ]Severe Neurodevelopmental Disability will be assessed at discharge from hospital and at 18-24 months of age to assess developmental delay and cerebral palsy using the Bayley Scale of Infant Development II.
Secondary Outcome Measures :
- Persistent Hypotension [ Time Frame: Duration of hypothermia therapy( ie during the first 96 hours) ]The development of persistently low blood pressure despite adequate measures to maintain normal blood pressure will be assessed and recorded throughout the hypothermia therapy.
- Pulmonary Hemorrhage [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of Pulmonary hemorrhage at any stage during the patient's hospital stay will be recorded.
- Intracranial Hemorrhage [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of Intracranial Hemorrhage at any stage during the patient's hospital stay will be recorded by serial head ultrasounds on day 1 , day 3 and as required.
- Pulmonary Hypertension [ Time Frame: Duration of Hypothermia therapy (ie during the first 96 hours) ]The development of pulmonary hypertension at any stage during the patient's hospital stay will be recorded.
- Prolonged Blood Coagulation time [ Time Frame: Duration of hypothermia therapy ( ie during the first 96 hours) ]The development of abnormal coagulation profile during hypothermia therapy will be recorded.
- Culture Proven sepsis [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of sepsis with a positive blood culture during the patient's hospital stay will be recorded.
- Necrotizing enterocolitis [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of necrotizing enterocolitis during the patient's hospital stay will be recorded.
- Cardiac Arrhythmias [ Time Frame: Duration of hypothermia therapy (ie during the first 96 hours) ]The development ofcardiac arrythmia during hypothermia therapy will be recorded.
- Thrombocytopenia [ Time Frame: Duration of hypothermia therapy (ie during the first 96 hours) ]The development of low platelet count (<20,000) during hypothermia therapy will be recorded
- Major venous thrombosis [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of major venous thrombosis or a major vein thrombus during the patient's hospital stay will be recorded.
- Renal Failure [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of renal failure during the patient's hospital stay will be recorded
- Abnormal liver funcion tests (elevated liver enzymes) [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The devlopment of raised liver enzymes during the patient's hospital stay will be recorded.
- Pneumonia [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of pneumonia during the patient's hospital stay will be assessed and recorded.
- Pulmonary air leak syndrome [ Time Frame: Duration of hospital stay, an expected average of up to 4 weeks ]The development of pulmonary air leak syndrome during the patient's hospital stay will be recorded.
- Prolonged vs shortened hospital stay [ Time Frame: First day of NICU admission till the day of discharge, an expected average of up to 4 weeks ]The entire duration of hopital stay will be assessed
- Neurodevelopment score [ Time Frame: On the day of discharge from hospital, an expected average of 4 weeks after admission ]A developmental paediatrician blinded to the study groups will assess the patient's neurodevlopment on the day of his or her discharge.
- Abnormal aEEG [ Time Frame: Before randomization and during hypothermia therapy (0 hours till 96 hours) ]The aEEG is used to measure the severity of Hypoxic Ischemic Encephalopathy (moderate or severe).
- Presence of multiple handicaps [ Time Frame: 18-24 months of age ]Multiple handicaps (( defined as the presence of any two of the following in an infant at the age of 18-24 months: neuromotor disability (level 3-5 on GMF Classification), mental delay (Bayley MDI score <70),epilepsy, cortical visual impairment, sensorineural hearing loss)).
- Bayley Psychomotor Development Score less than 70 [ Time Frame: 18-24 months of age ]
- Sensorineural hearing loss equal to, or more than, 40 dB [ Time Frame: 18-24 months of age ]
- Epilepsy [ Time Frame: 18-24 months of age ]Epilepsy is defined as recurrent seizures beyond the neonatal period, requiring anticonvulsant therapy at the time of assessment
- Microcephaly [ Time Frame: 18-24 months of age ]Defined as Head circumference more than 2 standard deviations below the mean
- Result of EEG or MRI [ Time Frame: within the first 14 days of life ]To moniter any abnormal EEG patterns and any evidence of Ischemic/Hemorrhagic lesions on MRI
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| Ages Eligible for Study: | up to 6 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
The babies will be assessed sequentially by criteria A, B and C listed below:
A. Evidence of Perinatal Asphyxia at birth: Infants ≥35 completed weeks gestation admitted to the NICU with at least one of the following:
- Apgar score of <5 at 10 minutes after birth
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
- Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord arterial or venous pH <7.00 or otherwise arterial or capillary pH <7.00)
- Base Deficit (-16 mmol/L or more) in umbilical cord or any blood sample (arterial, venous or capillary) within 60 minutes of birth
Infants that meet criteria A will be assessed for whether they meet the neurological abnormality entry criteria (B) by trained personnel:
B. Clinical Evidence of Moderate to severe encephalopathy, consisting of altered state of consciousness (lethargy, stupor or coma) AND at least one of the following:
- hypotonia
- abnormal reflexes including oculomotor or pupillary abnormalities
- absent or weak suck
- clinical seizures
Infants who meet criteria A & B will be assessed by aEEG only in units where facility for Cerebral Function Monitoring (CFM) is available.
C. (Optional) At least 30 minutes duration of amplitude integrated EEG recording that shows abnormal background aEEG activity or seizures. There must be one of the following:
- normal background with some seizure activity
- continuous seizure activity
- moderately abnormal activity: Only Lower border below 5 mV. upper border remains above 10mV
- Severely Abnormal activity (suppressed activity): Both Lower border below 5 mV and upper border below 10mV
Exclusion Criteria:
- Infants expected to be > 6 hours of age at the time of randomization.Every effort will be made to ensure entry to the study before 3 hours of age.
- Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that includes brain dysgenesis.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646619
Contacts
| Contact: Sarrah A Y Eltinay, MBBS | +974-44398940 | magcoolcoordinator@gmail.com | |
| Contact: Sajjad Ur Rahman, MBBS.DCH.MCPS.FCPS.FRCPCH.FNP | +974-44396123 | Srahman4@hmc.org.qa |
Locations
| Egypt | |
| Mansoura University Children's Hospital | Recruiting |
| Mansoura, Egypt | |
| Contact: Islam A Noor, MD +20103893026 islamnoor79@yahoo.com | |
| Contact: Prof. Mohammed T Khashaba +20502317925 khashabamohamed@hotmail.com | |
| Principal Investigator: Mohamed T Khashaba | |
| Malaysia | |
| University Malaya Medical Center (UMMC) | Recruiting |
| Kuala Lumpur, Malaysia | |
| Contact: Lucy CS Lum, Prof 60379492065 lumcs@ummc.edu.my | |
| Contact: Hasimah B Zainol, Nursing 03-79492428/ 016-6217549 hasimah@ummc.edu.my | |
| Principal Investigator: Lucy CS Lum, Professor | |
| Qatar | |
| NICU,Women's Hospital, Hamad Medical Corporation | Recruiting |
| Doha, Qatar, 00000 | |
| Contact: Sarrah A Eltinay, MBBS +974-44398940 magcoolcoordinator@gmail.com | |
| Contact: Sajjad Ur Rahman, MBBS,DCH,MCPS,FCPS,FRCPCH,FNP +974-44396123 magcoolstudy@hotmail.com | |
| Sub-Investigator: Samawal Lutfi, MD, CABP, NPM (Dalhousie) | |
| Sub-Investigator: Hussain Parappil, MBBS,MD,DCH,FRCPCH | |
| Saudi Arabia | |
| Arrayan Hospital-Dr Sulaiman Al Habib Medical Group | Recruiting |
| Riyadh, Saudi Arabia | |
| Contact: Jassim Anabrees, MD,MRCPCH +96614904000 ext 9690 jasim1800@yahoo.com | |
| Principal Investigator: Jassim Anabress, MD | |
| Turkey | |
| Zekai Tahir Burak Maternity Teaching Hospital | Recruiting |
| Ankara, Turkey | |
| Contact: Fuat E Canpolat, MD +905326315185 femrecan@gmail.com | |
| Contact: Prof. Ugur Dilmen +903123065267 ugurdilmen@gmail.com | |
| Principal Investigator: Fuat E Canpolat, MD | |
| Diyarbakir Children's Hospital | Recruiting |
| Diyarbakir, Turkey | |
| Contact: Melek Akar, MD 904122245751507 Melek_akar@yahoo.com.tr | |
| Contact: Heybet Tuzun, Pharm drheybet@hotmail.com | |
| Principal Investigator: Melek Akar, MD | |
| Sub-Investigator: Heybet Tuzun, Pharm | |
| United Arab Emirates | |
| Tawam Hospital | Recruiting |
| AlAin, United Arab Emirates | |
| Contact: Aiman Rahmani, MD 97137072181 arahmani@tawamhospital.ae | |
| Contact: Fares Chedid, MD 971504474661 fchedid@tawamhospital.ae | |
| Principal Investigator: Aiman Rahmani, MD | |
| Sub-Investigator: Fares Chedid, MD | |
| Sub-Investigator: Moghis Rehman, MD | |
Sponsors and Collaborators
Sajjad Rahman
Investigators
| Principal Investigator: | Sajjad Ur Rahman, MBBS.DCH.MCPS.FCPS.FRCPCH.FNP | Hamad Medical Corporation |
Publications:
| Responsible Party: | Sajjad Rahman, Senior Consultant Perinatal Medicine, Hamad Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT01646619 History of Changes |
| Other Study ID Numbers: |
GC 1028A HMC-GC1028A ( Other Identifier: Hamad Medical Corporation ) |
| First Posted: | July 20, 2012 Key Record Dates |
| Last Update Posted: | April 4, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Sajjad Rahman, Hamad Medical Corporation:
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Hypoxic Ischemic Encephalopathy Therapeutic Hypothermia Therapeutic Hypothermia plus Adjuvant Therapy Cooling |
Additional relevant MeSH terms:
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Brain Diseases Brain Ischemia Hypoxia-Ischemia, Brain Ischemia Hypothermia Hypoxia Pathologic Processes Central Nervous System Diseases Nervous System Diseases Body Temperature Changes Signs and Symptoms Signs and Symptoms, Respiratory Cerebrovascular Disorders Vascular Diseases Cardiovascular Diseases |
Hypoxia, Brain Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Tocolytic Agents |