| 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
|
|
|
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
|
|
|
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
|
|
|
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 |
|
|
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. |