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CTRI Number  CTRI/2025/03/082292 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   A retrospective study on changing antibiotics sensitivity pattern in NICU at tertiary care hospital 
Scientific Title of Study   Trends and Patterns of Antibiotic Resistance Among Pathogens in Neonatal Sepsis at a Tertiary Care Hospital: A Five-Year 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  Dr Vikrant Deshmukh 
Designation  DM Neonatology senior resident 
Affiliation  Bharati Vidyapeeth Deemed to be University Medical college and RC, Pune 
Address  Department of Neonatology, second floor, Bharati vidyapeeth Medical college, Pune-411043.

Pune
MAHARASHTRA
411043
India 
Phone  9096015474  
Fax    
Email  vikrant.deshmukh40@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandini Malshe 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University Medical college and RC, Pune 
Address  Department of Neonatology, second floor, Bharati vidyapeeth Medical college, Pune-411037.

Pune
MAHARASHTRA
411043
India 
Phone  9822850716  
Fax    
Email  malshenandini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nandini Malshe 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University Medical college and RC, Pune 
Address  Department of Neonatology, second floor, Bharati vidyapeeth Medical college, Pune-411037.

Pune
MAHARASHTRA
411043
India 
Phone  9822850716  
Fax    
Email  malshenandini@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Medical College 
Address  Bharati Vidyapeeth deemed to be Medical college and RC, Pune, Maharashtra. -411043 
Type of Sponsor  Private medical college 
 
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 Vikrant Deshmukh  Bharati Hospital   NICU, second floor, Department of Neonatology, Bharati Vidyapeeth Deemed to be University Medical College and Hospital, Pune.
Pune
MAHARASHTRA 
9096015474

vikrant.deshmukh40@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P368||Other bacterial sepsis of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates with suspected sepsis who undergo Blood, CSF, or
Urine culture testing will be included. 
 
ExclusionCriteria 
Details  Cases with no medical records available
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To investigate the prevalence of
bloodstream infections (BSI), urinary tract infections (UTI), and cerebrospinal fluid (CSF) infections in neonates admitted
to the neonatal unit in past 5 years. 
5 years from January 2020 till December 2024 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the spectrum of causative pathogens associated with neonatal sepsis.  5 years from January 2020 till December 2024 
To evaluate the antimicrobial susceptibility of the isolated pathogens to commonly used antibiotics.  5 years from January 2020 till December 2024 
To analyse trends in the prevalence and
antimicrobial resistance of blood and CSF infections over the 5 year period. 
5 years from January 2020 till December 2024 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   24/03/2025 
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="2"
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  

Summary

This five-year retrospective observational study aims to analyze the trends and patterns of antibiotic resistance among pathogens in neonatal sepsis at the Neonatal Intensive Care Unit (NICU) of Bharati Vidyapeeth Medical College Hospital, Pune. The primary objective is to assess the prevalence of bloodstream infections (BSI), urinary tract infections (UTI), and cerebrospinal fluid (CSF) infections in neonates admitted between January 2020 and December 2024. Secondary objectives include identifying the spectrum of causative pathogens, evaluating their antimicrobial susceptibility, and analyzing trends in antimicrobial resistance over the study period. All neonates with suspected sepsis who underwent blood, CSF, or urine culture testing during the study period will be included. Data will be collected retrospectively from the Department of Microbiology, focusing on culture positivity and antibiotic sensitivity. Statistical analysis will be conducted using SPSS v29 software, ensuring patient confidentiality. The study will provide critical insights into the evolving patterns of antibiotic resistance in neonatal sepsis, aiding in the optimization of empirical antibiotic therapy and infection control strategies. Findings from this research will help improve clinical management and antibiotic stewardship programs in NICUs, ultimately reducing neonatal morbidity and mortality associated with sepsis.

 
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