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CTRI Number  CTRI/2025/03/083270 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 23/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   retrospective study 
Study Design  Other 
Public Title of Study   study of demographics, clinical, laboratory, circulatory changes of babies less than 28 days of life having fungus infection 
Scientific Title of Study   study of demographics, clinical, laboratory and haemodynamic profile of neonates with fungal sepsis: A 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  Arshdeep Kaur 
Designation  senior resident 
Affiliation  bharati vidyapeeth hospital and research centre 
Address  NICU 2nd floor Bharati vidyapeeth hospital and research centre dhankawadi Pune

Pune
MAHARASHTRA
411043
India 
Phone  09815961268  
Fax    
Email  arshdeepk0192@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nandini malshe  
Designation  Professor, department of neonatology  
Affiliation  Bharati vidyapeeth hospital and research centre 
Address  NICU 2nd floor Bharati vidyapeeth hospital and research centre dhankawadi Pune

Pune
MAHARASHTRA
411043
India 
Phone  9822850716  
Fax    
Email  malshenandini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nandini malshe  
Designation  Professor, department of neonatology  
Affiliation  Bharati vidyapeeth hospital and research centre 
Address  NICU 2nd floor Bharati vidyapeeth hospital and research centre dhankawadi Pune


MAHARASHTRA
411043
India 
Phone  9822850716  
Fax    
Email  malshenandini@gmail.com  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  Bharati hospital 
Address  Bharati vidyapeeth hospital and research centre,Pune-Satara Road, Pune-411043,Maharashtra,INDIA 
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 Arshdeep Kaur  Bharati hospital   NICU 2nd floor Bharati vidyapeeth hospital and research centre dhankawadi Pune NICU 2nd floor Bharati vidyapeeth hospital and research centre dhankawadi Pune
Pune
MAHARASHTRA 
09815961268

arshdeepk0192@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati vidyapeeth deemed to be university medical college institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P398||Other specified infections specific to the perinatal period,  
 
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 from 0 to 28 days of life admitted to Bharati Hospital NICU between year 2022 to 2025 with fungal culture positive will be included in the study. 
 
ExclusionCriteria 
Details  N/A 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To retrospectively investigate the clinical, laboratory, and hemodynamic characteristics of newborns admitted to Bharati NICU with fungal sepsis between 2022 and 2025.  2022 to 2025 (3 years ) 
 
Secondary Outcome  
Outcome  TimePoints 
A study to evaluate the clinical, demographic, and laboratory profiles of newborns admitted to the Bharati NICU from 2022 to 2025, with an emphasis on haemodynamic parameters, antibiotic sensitivity, and clinical outcomes.  2022 to 2025 (3 years ) 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   03/04/2025 
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  

INTRODUCTION

While bacterial sepsis is one of the major causes of neonatal mortality globally and nationally, fungal sepsis has alarmingly come up in the last two decades [1]. Increase in preterm deliveries with more number of very low birth weight (VLBW) and extremely low birth weight (ELBW) neonates is the commonest associated risk factor for increase in fungal sepsis. The overall mortality due to fungal sepsis is around 50% in VLBW and higher in ELBW neonates [2]. Although, the most common species isolated is Candida albicans, there has been a surge in non-albicans Candida species outbreaks which was isolated in 30-90% cases in India [3]. The studied clinical spectrum of fungal sepsis includes incidence of respiratory distress, shock, necrotising enterocolitis, hyperglycaemia, meningitis, solid organ abscess, endocarditis, endophthalmitis among others [3-6]. The associated cardiac findings include an intracardiac mass and endocarditis [7]. However, the functional echocardiographic parameters in fungal sepsis remain unexplored. Through this reterospective observational study, we will be discussing clinical, laboratory, ultrasonography and echocardiographic profile of last three years.

AIM AND OBJECTIVES

AIM

To retrospectively investigate the clinical, laboratory, and hemodynamic characteristics of newborns admitted to Bharati NICU with fungal sepsis between 2022 and 2025.

 

PRIMARY OBJECTIVES

A study to evaluate the clinical, demographic, and laboratory profiles of newborns admitted to the Bharati NICU from 2022 to 2025, with an emphasis on haemodynamic parameters, antibiotic sensitivity, and clinical outcomes.

 

MATERIAL AND METHODS

Study design: Retrospective observational study

Duration of study: The enrolment period will be between year 2022 to 2025

Sample size:  all neonates from 0 to 28 days of life admitted in Bharati hospital NICU between year 2022 to 2025, with fungal culture (blood, CSF, urine) positive will be included in sample size

Setting: Tertiary care Neonatal Intensive Care Unit (NICU), Department of Neonatology, Bharati Vidyapeeth (Deemed to Be University) Medical College Hospital Research Centre, Pune.

Inclusion criteria: all neonates from 0 to 28 days of life admitted to Bharati Hospital NICU between year 2022 to 2025 with fungal culture positive will be included in the study.

 

 

 

Method:

After ethical committee approval. This retrospective study will be conducted between year 2022 to 2025 in a tertiary care NICU of Bharati Vidyapeeth medical college and research centre, Pune. Data of all new borns less than 28 days of life admitted in NICU in defined time period in whom fungal organism was isolated in any of the culture (blood, CSF, urine) collected from records.  Data about following parameters demographics, risk factors, clinical parameters, laboratory parameters, culture reports (blood, CSF, urine) along with sensitivity pattern 2D ECHO, renal, abdominal and cranial ultrasonography, fundus examination will also be retrieved. All the data will be analysed statistically. Personal information of the patient will be kept anonymous.

 
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