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CTRI Number  CTRI/2025/06/089368 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Can a medication based scoring system to identify heart problems in newborns who have not cried at birth. A retrospective study from a single centre. 
Scientific Title of Study   Validity of VIS score as hemodynamic predictor of mortality in neonates with moderate to severe HIE: A single centre retrospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shaik Mohammed Munthakheem 
Designation  Senior Resident 
Affiliation  Maharashtra university of health sciences 
Address  2nd Floor, Surgical building,GHATI hospital, Government medical college
Flat no 7, A wing, Gulshan apartment, Jalan nagar
Aurangabad
MAHARASHTRA
431001
India 
Phone  09620107364  
Fax    
Email  munthakheem93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr L S Deshmukh  
Designation  Professor and Head 
Affiliation  Government medical college ,Maharashtra university of health sciences 
Address  Department of Neonatology, 2nd Floor, Surgical building,GHATI hospital, Government medical college

Aurangabad
MAHARASHTRA
431001
India 
Phone  09620107364  
Fax    
Email  deshmukhls@yahoo.com   
 
Details of Contact Person
Public Query
 
Name  Dr L S Deshmukh  
Designation  Professor and Head 
Affiliation  Government medical college ,Maharashtra university of health sciences 
Address  Department of Neonatology, 2nd Floor, Surgical building,GHATI hospital, Government medical college

Aurangabad
MAHARASHTRA
431001
India 
Phone  09620107364  
Fax    
Email  deshmukhls@yahoo.com   
 
Source of Monetary or Material Support  
Government medical college (GHATI) Aurangabad,Maharashtra 431001  
 
Primary Sponsor  
Name  Shaik Mohammed Munthakheem  
Address  Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001  
Type of Sponsor  Other [Principal investigator] 
 
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 Shaik Mohammed Munthakheem  Government medical college (GHATI)   Department of Neonatology, 2nd Floor, Surgical building,GHATI hospital, Government medical college Flat no 7, A wing, Gulshan apartment, Jalan nagar
Aurangabad
MAHARASHTRA 
09620107364

munthakheem93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Govt Medical college aurangabad ( IEC-GMCA )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P298||Other cardiovascular disorders originating in the perinatal period,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  all neonates with moderate and severe HIE 
 
ExclusionCriteria 
Details  Encephalopathy unlikely due to HI
Major life threatening congenital anomaly
Death within 6 hrs of admission
Birth weight less than 1800 g
With incomplete medical records were excluded
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of VIS scores with mortality in the first 72 hours at different time points (6, 12, 24, 48 and 72 hours of life) in neonates with moderate to severe encephalopathy.
 
Death or 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study VIS score and its correlation with
composite outcome of death or abnormal MRI at discharge
RI day 1 in the anterior cerebral artery
Duration of mechanical ventilation
AKI
Any ventricular dysfunction at 24 hours 
Death or 28 days 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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   N/A 
Date of First Enrollment (India)   16/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  16/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The essential component to neonatal adaptation after birth is the initiation of adequate respiratory effort. Approximately 10–15% of newborns require support for respiratory transition at birth, 3% require positive pressure ventilation by mask, 2% intubation, and only <1% cardiopulmonary resuscitation with chest compressions or epinephrine to establish cardiorespiratory function .

The major cause for delivery room cardiopulmonary resuscitation is birth asphyxia, a condition of insufficient oxygen supply to vital organs that results in hypoxia, hypercarbia, and metabolic acidosis and, if prolonged, may progress to multiorgan failure, including the developing brain, which is then referred to as hypoxic ischemic encephalopathy.

 Birth asphyxia accounts for 900,000 neonatal deaths worldwide annually and hypoxic– ischemic encephalopathy is estimated to cause up to a quarter of all postnatal deaths . In developed countries, birth asphyxia occurs in 1.5–2.5 per 1000 live births and is one of the major causes for the development of cerebral palsy . In 2002-2003, the National Neonatal Perinatal Database (NNPD), a network of neonatal units in India comprising of 18 units across the country, reported that the incidence of HIE was 1.4% among institutional deliveries, and perinatal asphyxia was the commonest primary cause of neonatal mortality (28.8%) and stillbirth (45.1%) [9].A recent systematic analysis of global, national, and regional causes of child mortality identified HIE as the third important cause (20%) of neonatal deaths in India . However, data about the various factors influencing the outcome are lacking.Therapeutic hypothermia (TH) is the standard of care for HIE in developed countries, but the adoption rate and techniques may differ in low- and middle income countries (LMICs).This study is aimed to look at short term outcomes and factors associated with decreased survival in term infants with moderate to severe HIE.

Vasopressors and inotropes, together referred to as cardioactive therapies, are frequently used for the management of cardiovascular dysfunction in the neonatal intensive care unit (NICU). Previous work has highlighted the association between exposure to cardioactive therapies and higher incidences of adverse outcomes in preterm neonates, including mortality and neurodevelopmental impairment. But the same has not been validated in terms with asphyxia

The aim of the present study was to evaluate the accuracy of the VIS score for predicting in-hospital mortality (sensitivity, specificity) following moderate to severe hypoxic–ischemic encephalopathy 

 
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