Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy (MagCool)
This study is currently recruiting participants.
Verified April 2013 by Hamad Medical Corporation
Sponsor:
Sajjad Rahman
Information provided by (Responsible Party):
Sajjad Rahman, Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01646619
First received: July 5, 2012
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Severe Hypoxic Ischemic Encephalopathy Moderate Hypoxic Ischemic Encephalopathy |
Drug: Magnesium Sulphate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Hamad Medical Corporation:
Primary Outcome Measures:
- Combined outcome of Mortality and Severe Neurodevelopmental Disability [ Time Frame: 18 - 24 months of age ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]The development ofcardiac arrythmia during hypothermia therapy will be recorded.
- Thrombocytopenia [ Time Frame: Duration of hypothermia therapy (ie during the first 96 hours) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Sensorineural hearing loss equal to, or more than, 40 dB [ Time Frame: 18-24 months of age ] [ Designated as safety issue: No ]
- Epilepsy [ Time Frame: 18-24 months of age ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]To moniter any abnormal EEG patterns and any evidence of Ischemic/Hemorrhagic lesions on MRI
| Estimated Enrollment: | 300 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
Website used to randomly assign patients to a randomization arm through a unique randomization code.
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 |
| Study First Received: | July 5, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | Qatar: Hamad Medical Corporation |
Keywords provided by Hamad Medical Corporation:
|
Hypoxic Ischemic Encephalopathy Therapeutic Hypothermia Therapeutic Hypothermia plus Adjuvant Therapy Cooling |
Additional relevant MeSH terms:
|
Brain Ischemia Hypothermia Ischemia Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Hypoxia-Ischemia, Brain Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Body Temperature Changes Signs and Symptoms Pathologic Processes Confusion Neurobehavioral Manifestations Neurologic Manifestations Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013