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CTRI Number  CTRI/2025/02/079861 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 30/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Accuracy of Systemic Inflammatory Markers in identifying Neonatal Sepsis 
Scientific Title of Study   Accuracy of Systemic Inflammatory Indices in identifying Neonatal Sepsis in preterms in a tertiary care hospital in Mangalore 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
-  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Smrithi GM 
Designation  MBBS Intern 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, Kasturba Medical College, Mangalore - 575001.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9176738968  
Fax    
Email  smrithi.g@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Gayathri Renganathan 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, Kasturba Medical College, Mangalore - 575001.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9632866222  
Fax    
Email  gayathri.renganathan@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Gayathri Renganathan 
Designation  Assistant Professor  
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Pediatrics, Kasturba Medical College, Mangalore - 575001.

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9632866222  
Fax    
Email  gayathri.renganathan@manipal.edu  
 
Source of Monetary or Material Support  
Government Lady Goschen Hospital, Mangaluru, Karnataka - 575001, India. 
 
Primary Sponsor  
Name  Smrithi GM 
Address  Department of Pediatrics, Kasturba Medical College, Mangalore - 575001, Karnataka, India. 
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 Smrithi GM  Government Lady Goschen Hospital  Neonatal Intensive Care Unit (NICU), Third floor, Government Lady Goschen Hospital, Mangaluru, Dakshina Kannada, Karnataka - 575001, India.
Dakshina Kannada
KARNATAKA 		 9176738968

smrithineha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Medical College, Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL intervention  NIL intervention 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Preterm neonates in NICU 
 
ExclusionCriteria 
Details  i. Term Neonates admitted to NICU.
ii. Healthy newborns in postnatal wards.
iii. Not willing to participate.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the value of lab based diagnostic indices in early diagnosis of neonatal sepsis in preterms  Evaluate lab based diagnostic indices, taken 24 hours after birth. 
 
Secondary Outcome  
Outcome  TimePoints 
-  - 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   10/02/2025 
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="0"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [smrithi.g@learner.manipal.edu].

  6. For how long will this data be available start date provided 30-11-2024 and end date provided 31-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Sepsis is a life threatening illness in neonates, in both term and preterm babies. Neonatal sepsis accounts for about 8% of neonatal fatalities. This study aims to assess the value of lab based diagnostic indices as a predictor of Neonatal Sepsis in preterms.  
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