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
|
|
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
|
|
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. |