| 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
|
|
|
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
|
|
|
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 |