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
|
|
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
|
|
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
|
|
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.
|