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Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy (MagCool)

Primary Purpose

Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Magnesium Sulphate
Placebo
Sponsored by
Sajjad Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Severe Hypoxic Ischemic Encephalopathy focused on measuring Hypoxic Ischemic Encephalopathy, Therapeutic Hypothermia, Therapeutic Hypothermia plus Adjuvant Therapy, Cooling

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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:

  1. Apgar score of <5 at 10 minutes after birth
  2. Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
  3. 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)
  4. 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:

  1. hypotonia
  2. abnormal reflexes including oculomotor or pupillary abnormalities
  3. absent or weak suck
  4. 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:

  1. normal background with some seizure activity
  2. continuous seizure activity
  3. moderately abnormal activity: Only Lower border below 5 mV. upper border remains above 10mV
  4. 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.

Sites / Locations

  • Mansoura University Children's HospitalRecruiting
  • University Malaya Medical Center (UMMC)Recruiting
  • NICU,Women's Hospital, Hamad Medical CorporationRecruiting
  • Arrayan Hospital-Dr Sulaiman Al Habib Medical GroupRecruiting
  • Zekai Tahir Burak Maternity Teaching HospitalRecruiting
  • Diyarbakir Children's HospitalRecruiting
  • Tawam HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypothermia + Magnesium Sulphate

Hypothermia+ Placebo

Arm Description

Outcomes

Primary Outcome Measures

Combined outcome of Mortality and Severe Neurodevelopmental Disability
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
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
The development of Pulmonary hemorrhage at any stage during the patient's hospital stay will be recorded.
Intracranial Hemorrhage
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
The development of pulmonary hypertension at any stage during the patient's hospital stay will be recorded.
Prolonged Blood Coagulation time
The development of abnormal coagulation profile during hypothermia therapy will be recorded.
Culture Proven sepsis
The development of sepsis with a positive blood culture during the patient's hospital stay will be recorded.
Necrotizing enterocolitis
The development of necrotizing enterocolitis during the patient's hospital stay will be recorded.
Cardiac Arrhythmias
The development ofcardiac arrythmia during hypothermia therapy will be recorded.
Thrombocytopenia
The development of low platelet count (<20,000) during hypothermia therapy will be recorded
Major venous thrombosis
The development of major venous thrombosis or a major vein thrombus during the patient's hospital stay will be recorded.
Renal Failure
The development of renal failure during the patient's hospital stay will be recorded
Abnormal liver funcion tests (elevated liver enzymes)
The devlopment of raised liver enzymes during the patient's hospital stay will be recorded.
Pneumonia
The development of pneumonia during the patient's hospital stay will be assessed and recorded.
Pulmonary air leak syndrome
The development of pulmonary air leak syndrome during the patient's hospital stay will be recorded.
Prolonged vs shortened hospital stay
The entire duration of hopital stay will be assessed
Neurodevelopment score
A developmental paediatrician blinded to the study groups will assess the patient's neurodevlopment on the day of his or her discharge.
Abnormal aEEG
The aEEG is used to measure the severity of Hypoxic Ischemic Encephalopathy (moderate or severe).
Presence of multiple handicaps
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
Sensorineural hearing loss equal to, or more than, 40 dB
Epilepsy
Epilepsy is defined as recurrent seizures beyond the neonatal period, requiring anticonvulsant therapy at the time of assessment
Microcephaly
Defined as Head circumference more than 2 standard deviations below the mean
Result of EEG or MRI
To moniter any abnormal EEG patterns and any evidence of Ischemic/Hemorrhagic lesions on MRI

Full Information

First Posted
July 5, 2012
Last Updated
April 3, 2013
Sponsor
Sajjad Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT01646619
Brief Title
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
Acronym
MagCool
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sajjad Rahman

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Perinatal Asphyxia continues to be a major cause of neonatal mortality and morbidity even in the most technologically advanced and prosperous countries of the world. The incidence remains unchanged; 1-2% of live births in developed world countries and much higher in developing world countries. Perinatal Asphyxia is a multisystem disorder. Neonatal brain is the most important organ affected by Asphyxic insult because the resulting neuronal damage is permanent. Hypoxic Ischemic Encephalopathy (HIE), the pathognomonic clinical syndrome of asphyxic neuronal insult, occurs in 50-60% of babies with Perinatal Asphyxia. Moderate and severe HIE causes significant neonatal mortality and morbidity. Among patients with moderate HIE, 10-20% die and 30-40% develop neurological deficit, whereas 50% of patients with severe HIE die and almost all survivors develop neurological deficits. Hence the toll on the society continues to be very high in spite of dramatic improvements in neonatal intact survival, particularly in developed world countries. Until recent years, the management of HIE was limited to supportive intensive care only because there was no specific treatment available to rescue neurons during HIE. However, over the last decade, therapeutic Hypothermia, has emerged as a promising new therapy in reducing neonatal mortality and morbidity due to HIE. This is due to improved understanding of the physiology of neuronal damage during asphyxia insult. Hypoxic Ischemic Encephalopathy (HIE) is a dynamic process which evolves over a period of seventy two hours starting from the time of insult. Two distinct episodes of neuronal damage occur during this time: The immediate (primary) hypoxic insult followed by a latent period of recovery which lasts for almost six hours. This is followed by a much longer and profound period of secondary neuronal damage due to the release of chemical mediators. Therapeutic modalities which can potentially reduce the release of these chemical mediators will provide neuronal rescue. Moderate controlled hypothermia (33.5-34.5 0C) offered during the first 72 hours after the asphyxic insult is one such therapeutic modality which has been the subject of animal studies as well as extensive multicenter trails in human infants over the last two decades. The studies on animal models have not only confirmed the safety of moderate therapeutic hypothermia; they have also shown a dramatic neuronal rescue in experimental HIE model of lambs subjected to prolonged therapeutic hypothermia immediately after birth. This was followed by pilot RCT's in human infants; the outcomes of which were very encouraging. However a universal change of practice requires large well designed multicenter trails and Meta analyses. After having established therapeutic hypothermia as a safe and effective modality for neuroprotection in HIE, the neonatologists are facing a new question. Can the investigators enhance the neuroprotective effect of therapeutic hypothermia by adding other potential neuroprotective agents? These potential therapeutic agents include Xenon, Erythropoetin, Magnisium sulphate, Allopurinol, opoids, Topiramate, Inhaled Nitric Oxide (iNO), N-Acetylcystine, Minocycline and Melatonin.13,17 Due to their different mechanisms of action, it is likely that these neuroprotective therapies may add incrementally to the proven beneficial effects of hypothermia. Indeed hypothermia may buy additional time for these neuroprotective agents to act within an expanded 'therapeutic window'.13 These Hypothermia plus therapies are going to be the subject of many new RCT's worldwide over the next few years. Magnesium Sulphate, a potential neuroprotective agent, acts by reducing neuronal excitotoxicity. MgSO4 has long been used in Obstertrics as a tocolytic agent and has a proven neuroprotective effect in preterm babies born to mothers tocolyzed with MgSO4. A recently conducted RCT in human neonates has compared postnatal magnesium sulfate with placebo in the management of Neonatal HIE. This study, which did not use hypothermia therapy due to lack of facilities, has shown that treatment with MgSO4 improves neurologic outcomes at discharge in term neonates with severe perinatal asphyxia. The animal studies done by Knuckley's group has compared a combination of therapeutic hypothermia and MgSO4 with therapeutic hypothermia alone. In their rat model MgSO4 alone had a minimal beneficial effect. However, MgSO4 plus hypothermia had a significant beneficial effect in reducing the size of the post asphyxia infarct. This animal focal stroke model provides an intriguing suggestion that hypothermia plus MgSO4 provides an additive neuroprotection. No human studies have been done so far to test the difference between therapeutic hypothermia alone and therapeutic hypothermia plus MgSO4. Mag Cool Study (Hypothermia plus MgSO4 Vs Hypothermia plus placebo) will test this hypothesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
Keywords
Hypoxic Ischemic Encephalopathy, Therapeutic Hypothermia, Therapeutic Hypothermia plus Adjuvant Therapy, Cooling

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypothermia + Magnesium Sulphate
Arm Type
Active Comparator
Arm Title
Hypothermia+ Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulphate
Other Intervention Name(s)
MgSo4
Intervention Description
10% MgSo4 (100mg/ml) given in a dose of 250mg/kg IV q 24 hrly for 3 doses(2.5ml/kg). Diluent: Dextrose 5%.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline, 0.9% Sodium Chloride
Intervention Description
Normal Saline 0.9% Sodium Chloride is diluted in 5% Dextrose to be given as 2.5ml/kg IV q24 hrly for 3 doses.
Primary Outcome Measure Information:
Title
Combined outcome of Mortality and Severe Neurodevelopmental Disability
Description
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.
Time Frame
18 - 24 months of age
Secondary Outcome Measure Information:
Title
Persistent Hypotension
Description
The development of persistently low blood pressure despite adequate measures to maintain normal blood pressure will be assessed and recorded throughout the hypothermia therapy.
Time Frame
Duration of hypothermia therapy( ie during the first 96 hours)
Title
Pulmonary Hemorrhage
Description
The development of Pulmonary hemorrhage at any stage during the patient's hospital stay will be recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Intracranial Hemorrhage
Description
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.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Pulmonary Hypertension
Description
The development of pulmonary hypertension at any stage during the patient's hospital stay will be recorded.
Time Frame
Duration of Hypothermia therapy (ie during the first 96 hours)
Title
Prolonged Blood Coagulation time
Description
The development of abnormal coagulation profile during hypothermia therapy will be recorded.
Time Frame
Duration of hypothermia therapy ( ie during the first 96 hours)
Title
Culture Proven sepsis
Description
The development of sepsis with a positive blood culture during the patient's hospital stay will be recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Necrotizing enterocolitis
Description
The development of necrotizing enterocolitis during the patient's hospital stay will be recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Cardiac Arrhythmias
Description
The development ofcardiac arrythmia during hypothermia therapy will be recorded.
Time Frame
Duration of hypothermia therapy (ie during the first 96 hours)
Title
Thrombocytopenia
Description
The development of low platelet count (<20,000) during hypothermia therapy will be recorded
Time Frame
Duration of hypothermia therapy (ie during the first 96 hours)
Title
Major venous thrombosis
Description
The development of major venous thrombosis or a major vein thrombus during the patient's hospital stay will be recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Renal Failure
Description
The development of renal failure during the patient's hospital stay will be recorded
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Abnormal liver funcion tests (elevated liver enzymes)
Description
The devlopment of raised liver enzymes during the patient's hospital stay will be recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Pneumonia
Description
The development of pneumonia during the patient's hospital stay will be assessed and recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Pulmonary air leak syndrome
Description
The development of pulmonary air leak syndrome during the patient's hospital stay will be recorded.
Time Frame
Duration of hospital stay, an expected average of up to 4 weeks
Title
Prolonged vs shortened hospital stay
Description
The entire duration of hopital stay will be assessed
Time Frame
First day of NICU admission till the day of discharge, an expected average of up to 4 weeks
Title
Neurodevelopment score
Description
A developmental paediatrician blinded to the study groups will assess the patient's neurodevlopment on the day of his or her discharge.
Time Frame
On the day of discharge from hospital, an expected average of 4 weeks after admission
Title
Abnormal aEEG
Description
The aEEG is used to measure the severity of Hypoxic Ischemic Encephalopathy (moderate or severe).
Time Frame
Before randomization and during hypothermia therapy (0 hours till 96 hours)
Title
Presence of multiple handicaps
Description
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)).
Time Frame
18-24 months of age
Title
Bayley Psychomotor Development Score less than 70
Time Frame
18-24 months of age
Title
Sensorineural hearing loss equal to, or more than, 40 dB
Time Frame
18-24 months of age
Title
Epilepsy
Description
Epilepsy is defined as recurrent seizures beyond the neonatal period, requiring anticonvulsant therapy at the time of assessment
Time Frame
18-24 months of age
Title
Microcephaly
Description
Defined as Head circumference more than 2 standard deviations below the mean
Time Frame
18-24 months of age
Title
Result of EEG or MRI
Description
To moniter any abnormal EEG patterns and any evidence of Ischemic/Hemorrhagic lesions on MRI
Time Frame
within the first 14 days of life

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarrah A Y Eltinay, MBBS
Phone
+974-44398940
Email
magcoolcoordinator@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sajjad Ur Rahman, MBBS.DCH.MCPS.FCPS.FRCPCH.FNP
Phone
+974-44396123
Email
Srahman4@hmc.org.qa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajjad Ur Rahman, MBBS.DCH.MCPS.FCPS.FRCPCH.FNP
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Children's Hospital
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam A Noor, MD
Phone
+20103893026
Email
islamnoor79@yahoo.com
First Name & Middle Initial & Last Name & Degree
Prof. Mohammed T Khashaba
Phone
+20502317925
Email
khashabamohamed@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed T Khashaba
Facility Name
University Malaya Medical Center (UMMC)
City
Kuala Lumpur
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy CS Lum, Prof
Phone
60379492065
Email
lumcs@ummc.edu.my
First Name & Middle Initial & Last Name & Degree
Hasimah B Zainol, Nursing
Phone
03-79492428/ 016-6217549
Email
hasimah@ummc.edu.my
First Name & Middle Initial & Last Name & Degree
Lucy CS Lum, Professor
Facility Name
NICU,Women's Hospital, Hamad Medical Corporation
City
Doha
ZIP/Postal Code
00000
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarrah A Eltinay, MBBS
Phone
+974-44398940
Email
magcoolcoordinator@gmail.com
First Name & Middle Initial & Last Name & Degree
Sajjad Ur Rahman, MBBS,DCH,MCPS,FCPS,FRCPCH,FNP
Phone
+974-44396123
Email
magcoolstudy@hotmail.com
First Name & Middle Initial & Last Name & Degree
Samawal Lutfi, MD, CABP, NPM (Dalhousie)
First Name & Middle Initial & Last Name & Degree
Hussain Parappil, MBBS,MD,DCH,FRCPCH
Facility Name
Arrayan Hospital-Dr Sulaiman Al Habib Medical Group
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jassim Anabrees, MD,MRCPCH
Phone
+96614904000
Ext
9690
Email
jasim1800@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jassim Anabress, MD
Facility Name
Zekai Tahir Burak Maternity Teaching Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuat E Canpolat, MD
Phone
+905326315185
Email
femrecan@gmail.com
First Name & Middle Initial & Last Name & Degree
Prof. Ugur Dilmen
Phone
+903123065267
Email
ugurdilmen@gmail.com
First Name & Middle Initial & Last Name & Degree
Fuat E Canpolat, MD
Facility Name
Diyarbakir Children's Hospital
City
Diyarbakir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melek Akar, MD
Phone
904122245751507
Email
Melek_akar@yahoo.com.tr
First Name & Middle Initial & Last Name & Degree
Heybet Tuzun, Pharm
Email
drheybet@hotmail.com
First Name & Middle Initial & Last Name & Degree
Melek Akar, MD
First Name & Middle Initial & Last Name & Degree
Heybet Tuzun, Pharm
Facility Name
Tawam Hospital
City
AlAin
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiman Rahmani, MD
Phone
97137072181
Email
arahmani@tawamhospital.ae
First Name & Middle Initial & Last Name & Degree
Fares Chedid, MD
Phone
971504474661
Email
fchedid@tawamhospital.ae
First Name & Middle Initial & Last Name & Degree
Aiman Rahmani, MD
First Name & Middle Initial & Last Name & Degree
Fares Chedid, MD
First Name & Middle Initial & Last Name & Degree
Moghis Rehman, MD

12. IPD Sharing Statement

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18753646
Citation
Rouse DJ, Hirtz DG, Thom E, Varner MW, Spong CY, Mercer BM, Iams JD, Wapner RJ, Sorokin Y, Alexander JM, Harper M, Thorp JM Jr, Ramin SM, Malone FD, Carpenter M, Miodovnik M, Moawad A, O'Sullivan MJ, Peaceman AM, Hankins GD, Langer O, Caritis SN, Roberts JM; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. A randomized, controlled trial of magnesium sulfate for the prevention of cerebral palsy. N Engl J Med. 2008 Aug 28;359(9):895-905. doi: 10.1056/NEJMoa0801187.
Results Reference
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PubMed Identifier
19349375
Citation
Bhat MA, Charoo BA, Bhat JI, Ahmad SM, Ali SW, Mufti MU. Magnesium sulfate in severe perinatal asphyxia: a randomized, placebo-controlled trial. Pediatrics. 2009 May;123(5):e764-9. doi: 10.1542/peds.2007-3642. Epub 2009 Apr 6.
Results Reference
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Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy

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