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CTRI Number  CTRI/2024/04/066212 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Tools to predict early mortality in neonates with moderate to severe birth asphyxia an observational study 
Scientific Title of Study   Early predictors of Mortality in babies with birth asphyxia having moderate or severe encephalopathy - An Observational 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  Government medical college 
Address  B6-304,my world apartments, opposite airport,chikalthana,Aurangabad Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9620107364  
Fax    
Email  munthakheem93@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shaik Mohammed Munthakheem 
Designation  Senior Resident 
Affiliation  Government medical college 
Address  B6-304,my world apartments, opposite airport,chikalthana,Aurangabad Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9620107364  
Fax    
Email  munthakheem93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shaik Mohammed Munthakheem 
Designation  Senior Resident 
Affiliation  Government medical college 
Address  B6-304,my world apartments, opposite airport,chikalthana,Aurangabad Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad

Aurangabad
MAHARASHTRA
431001
India 
Phone  9620107364  
Fax    
Email  munthakheem93@gmail.com  
 
Source of Monetary or Material Support  
Government medical college 
 
Primary Sponsor  
Name  Shaik Mohammed Munthakheem 
Address  B6-304,my world apartments, opposite airport,chikalthana,Aurangabad Department of Neonatology, 2nd Floor, Surgical Building, Government medical college (GHATI), Aurangabad, Maharashtra 431001 
Type of Sponsor  Other [Self] 
 
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  Department of Neonatology, 2nd floor, Surgical building, government medical college (GHATI) Aurangabad
Aurangabad
MAHARASHTRA 
9620107364

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: P916||Hypoxic ischemic encephalopathy [HIE],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  All inborn babies more than 37 weeks with moderated to severe encephalopathy developed within first 24 hours after birth as per NICHD criteria 
 
ExclusionCriteria 
Details  Neonates born with major congenital malformations, chromosomal abnormalities, or any metabolic disorders.Preterms less than 37 weeks 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Accuracy of the nSOFA for predicting in-hospital mortality (sensitivity, specificity) following hypoxic–ischemic encephalopathy  Death or discharge 
 
Secondary Outcome  
Outcome  TimePoints 
No of days of hospital stay
No of ventilation days (Invasive and Non invasive)
Need of AED’s
aEEG abnormalities
MRI abnormalities
Death / discharge. 
Death or discharge 
 
Target Sample Size   Total Sample Size="370"
Sample Size from India="370" 
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)   29/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 [1,2]. 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 [3, 4]. The neonatal modification of the SOFA (nSOFA) was proposed to address the need for a consensus definition of neonatal sepsis in 2020 [13]. nSOFA uses three objective and broadly available clinical parameters to quantify organ dysfunction: respiratory, cardiovascular, and hematological scores (total scores range from 0 to 15).  It was previously used for predicting mortality and severe morbidity in preterm infants [14], preterm infants with late onset sepsis [15], respiratory distress syndrome (RDS) [16], and neonates with proven sepsis [13,17]. Thus, the score was already shown to be predictive independent of the cause of organ dysfunction in the first 24 and 72 h.The aim of the present study was to evaluate the accuracy of the nSOFA for predicting in-hospital mortality (sensitivity, specificity) following moderate to severe hypoxic–ischemic encephalopathy

 
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