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CTRI Number  CTRI/2015/08/006107 [Registered on: 18/08/2015] Trial Registered Retrospectively
Last Modified On: 12/08/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A CLINICAL TRIAL TO SEE THE EFFECT OF MAGNESIUM SULFATE DRUG IN OXYGEN DEPRIVATED NEWBORN 
Scientific Title of Study   To study role of magnesium sulfate as a neuroprotective agent for perinata asphyxia in term neonates 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  vijay singh 
Designation  junior resident III 
Affiliation  maharani laxmi bai medical college, jhansi, uttar pradesh 
Address  room 80, department of pediatrics, M.L.B. Medical college, Jhansi
room 80, department of pediatrics, M.L.B. Medical college, Jhansi
Lucknow
UTTAR PRADESH
284128
India 
Phone  7309934373  
Fax    
Email  vijay.s.dr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  R S Sethi 
Designation  Professor 
Affiliation  maharani laxmi bai medical college, jhansi, uttar pradesh 
Address  room 80, department of pediatrics M.L.B. Medical college, Jhansi
Room 80 department of pediatrics maharani laxmi bai medical college jhansi
Lucknow
UTTAR PRADESH
284128
India 
Phone  7309934373  
Fax    
Email  drsethijhs@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  vijay singh 
Designation  junior resident III 
Affiliation  maharani laxmi bai medical college, jhansi, uttar pradesh 
Address  room 80, Department of pediatrics, M.L.B. Medical college, Jhansi

Lucknow
UTTAR PRADESH
284128
India 
Phone  7309934373  
Fax    
Email  vijay.s.dr@gmail.com  
 
Source of Monetary or Material Support  
Neonatology unit room 80, department of pediatrics, M.L.B. Medical college, Jhansi  
 
Primary Sponsor  
Name  MAHARANI LAXMI BAI MEDICAL COLLEGE JHANSI 
Address  ROOM 80 DEPARTMENT OF PEDIATRICS 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr vijay singh  Maharani Laxmi Bai Medical College, Jhansi, Uttar Pradesh  Neonatology unit, department of pediatrics, M.L.B. Medical college, Jhansi
Jhansi
UTTAR PRADESH 
7309934373

vijay.s.dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethical committee m.l.b. medical college jhansi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  neonates with perinatal asphyxia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  magnesium sulfate-drug  The treatment group received magnesium sulfate infusion at 250 mg/kg/dose in 20 ml of 5% dextrose solution in 1 hour OD for 3 days  
Comparator Agent  normal saline-placebo  The placebo group received 3 doses of normal saline at 1 ml/kg/dose in 20 ml of 5% dextrose solution OD for 3 days 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  0.25 Day(s)
Gender  Both 
Details  gestational age > 37 weeks , age < 6 hours, severe perinatal asphyxia 
 
ExclusionCriteria 
Details  patients with severe intrauterine growth retardation, any condition unrelated to asphyxia, age > 6 hours at admission, maternal disorder, chromosomal anomalies or congenital malformation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
neuroprotective  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
not hypotensive at given dose  1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This study is a randomized , triple blinded, parallel group placebo controlled trial to determine the role of magnesium sulfate in perinatal asphyxia. This study was conducted in fifty term neonates with perinatal asphyxia, who were selected in accordance with the laid down criteria. Neonates were assigned randomly to receive either 3 doses of magnesium sulfate infusion at 250 mg/kg/dose 24 hour apart (treatment group) or 3 doses of normal saline infusion at 1 ml/kg/dose 24 hour apart (placebo group). Calmagite method was used for estimation of serum magnesium sulfate levels. Distribution of neonatal baseline characteristics and severity of hypoxic ischemic encephalopathy were statistically similar in treatment and placebo groups. The mean serum magnesium concentration in the treatment group remained >1.4mEq/L in initial 72 hours. In our study, postnatal magnesium sulfate infusion was found neuroprotective in moderate encephalopathy, which was reflected by early control of seizures (p=0.04), early appearance of normal cry (p=0.02), early appearance of normal activity (p=0.02), early acceptance of full oral feed by sucking (p=0.04), good short term outcome (p=0.04). Postnatal magnesium sulfate infusion was not found neuroprotective in severe encephalopathy (p=>0.05). No significant differences were observed in blood pressure between both the groups. Finally, this was concluded that postnatal magnesium sulfate therapy causes fevorable neurological outcome as primary outcome and not causing hypotension at given dose as secondary outcome.
 
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