| CTRI Number |
CTRI/2018/06/014594 [Registered on: 20/06/2018] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Magnesium sulfate as an adjunct to cooling of babies who do not cry at birth. |
|
Scientific Title of Study
|
Magnesium sulfate as an adjunct to therapeutic hypothermia in the management of term infants with hypoxic ischemic encephalopathy: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Adhisivam B |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Neonatology, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488822113 |
| Fax |
|
| Email |
adhisivam1975@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Adhisivam B |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Neonatology, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488822113 |
| Fax |
|
| Email |
adhisivam1975@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adhisivam B |
| Designation |
Additional Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Neonatology, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488822113 |
| Fax |
|
| Email |
adhisivam1975@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Institute Intramural grant for the research,JIPMER,Puducherry |
|
|
Primary Sponsor
|
| Name |
JIPMER Puducherry |
| Address |
JIPMER, Puducherry, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chanchal Kumar |
JIPMER, Puducherry |
Department of Neonatlogy, JIPMER,Puducherry
Pondicherry
PONDICHERRY |
9592244321
drchanchalkumarkem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P916||Hypoxic ischemic encephalopathy [HIE], Term infants with Hypoxic Ischemic Encephalopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium sulfate and therapeutic hypothermia |
Term infants with hypoxic ischemic encephalopathy will receive magnesium sulfate as an adjunct to therapeutic hypothermia
Magnesium sulfate will be given as intravenous infusion over 30 minutes at the dose of 250 mg/kg for total 3 doses(first dose within 6 hours of birth, second dose after 24 hours of the first dose and third dose after 48 hours of the first dose. |
| Comparator Agent |
Therapeutic hypothermia alone |
Term infants with hypoxic ischemic encephalopathy will receive therapeutic hypothermia |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Inclusion criteria A plus B and any one of C
A. Inborn babies with Gestational age more than or equal to 37 weeks with Arterial blood gas(Umbilical cord or 1st postnatal hour) pH less than or equal to 7.0 or base deficit more than or equal to 12 meq/L
B. Presence of moderate to severe encephalopathy
C. Any one of the below mentioned criteria:
1. APGAR less than or equal to 5 at 10 minutes
2. Evidence of fetal distress
3. Assisted ventilation for at least 10 minutes after birth
4. Evidence of any organ dysfunction
5. History of acute perinatal event |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Infants more than 6 hours of age |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neonatal mortality and/or abnormal neurodevelopmental outcome at 1 year of age |
Neonatal mortality at 28 days of life and abnormal neurodevelopmental outcome at 1 year of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a.Neonatal mortality
b.Major neurodevelopmental disability at 1 year of age
c.Hospital course and discharge status-seizure, Anti-epileptic requirement
d.Adverse effects-Hypotension, respiratory depression, Hypermagnesemia
e.Oxidative stress marker ( serum level of Malondialdehyde and Total antioxidant status)
|
Neonatal mortality-28 days of life
Major neurodevelopmental outcome-1 year of age
Hospital course and discharge status-at discharge
adverse effects-first 72 hours of life
Oxidative stress marker-at birth and at 72 hours of life
|
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/07/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 |