| CTRI Number |
CTRI/2024/04/066153 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
AMBISPECTIVE OBSERVATION STUDY |
| Study Design |
Other |
|
Public Title of Study
|
To see sepsis rate in nicu |
|
Scientific Title of Study
|
To Study Incidence and clinical outcomes of culture positive sepsis in a Level III NICU – a ambispective observational 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 Sonali Amol Avale |
| Designation |
Senior Resident |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9850584999 |
| Fax |
|
| Email |
sonaliawale1193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmikant Deshmukh |
| Designation |
Head of Department of Neonatology |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmikant Deshmukh |
| Designation |
Head of Department of Neonatology |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Department of Neonatology , Government Medical college , Sambhaji Nagar |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Amol Avale |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar |
| Type of Sponsor |
Other [Self] |
|
|
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 Sonali Amol Avale |
Government Medical college , Sambhaji Nagar |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA |
9850584999
sonaliawale1193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College , Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All neonates with culture positive sepsis in NICU, Government medical College and Hospital Aurangabad from January 2021 to March 2025 |
|
| ExclusionCriteria |
| Details |
All neonates with sterile culture reports |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of MDR and XDR in NICU |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Mortality
• Duration of hospital stay
• Complications during stay
• CLABSI
• Meningitis
• VAP
• NEC
• ROP |
Death
Discharge |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
07/05/2024 |
| 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="1"
Months="0"
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
|
Sepsis is one of the three most common causes of
neonatal deaths globally. Most infection-related deaths in the neonatal period
occur in low-income and middle-income countries due to poor hygiene and
suboptimal practices for infection control. A significant proportion of these
deaths are caused by multidrug-resistant pathogens.Despite the massive
burden, few high-quality data about neonatal sepsis are available from these
countries.The currently available multisite studies on sepsis are from
well-established surveillance networks in high income countries such as the
USA, the UK, and Germany . Such infection surveillance networks are a
rarity in low-income and middle-income countries; the few available ones have
used passive surveillance ( the National Neonatal Perinatal Database [NNPD] and the Asia-Pacific Neonatal Infections Study [APNIS]. Most of the other
studies from low-income and middle-income countries are typically from a single
site, retrospective, or have relied on routine laboratory reports. They
often lack rigorous data collection and reporting methods, and run the risk of
misclassification and underestimation or overestimation of the incidence of
sepsis. The paucity of high-quality data has undermined the recognition
of neonatal sepsis as an area of serious concern in public health, the
implementation of measures aimed at improvement of health-systems, and
investments in research and innovation in low-income and middle-income
countries |