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CTRI Number  CTRI/2025/08/093647 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Single Arm Study 
Public Title of Study   Reducing the rates of infection among the sick newly born babies who are admitted to the sick newborn unit by using a set of care bundle , which will be developed in this study and we will see their effect on the infection rates. 
Scientific Title of Study   Development, implementation, and evaluation of a Neonatal Infection Reduction Bundle for sustained reduction in late-onset sepsis in the Neonatal Intensive Care Unit of a tertiary care hospital 
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 Suprabha K Patnaik 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth deemed to be university Medical college 
Address  Department of Neonatology, Bharati Vidyapeeth deemed to be university Medical college,Pune Satara Road, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9650138130  
Fax    
Email  suprabha.patnaik@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Suryawanshi 
Designation  Professor 
Affiliation  Bharati Vidyapeeth deemed to be university Medical college 
Address  Department of Neonatology, Bharati Vidyapeeth deemed to be university Medical college,Pune Satara Road, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9923540500  
Fax    
Email  drpradeepsuryawanshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suprabha K Patnaik 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth deemed to be university Medical college 
Address  Department of Neonatology, Bharati Vidyapeeth deemed to be university Medical college,Pune Satara Road, Dhankawadi, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9650138130  
Fax    
Email  suprabha.patnaik@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Hospital and Research centre Dhankawadi Pune Maharastra India Pincode 411043 
 
Primary Sponsor  
Name  Bharati Vidyapeeth deemed to be university medical college 
Address  Bharati Vidyapeeth deemed to be university Medical college,Pune Satara Road, Dhankawadi, Pune, Maharastra, India 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 Suprabha K Patnaik  Bharati hospital and research centre,Pune  Neonatal intensive care unit, second floor, Old building , Bharati Hospital and research centre, Pune Satara Road, Dhankawadi, Pune, Maharashtra, India, Pin code 411043
Pune
MAHARASHTRA 		 9650138130

suprabha.patnaik@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P36||Bacterial sepsis of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  neonatal infection reduction bundle  A set of care activities to be decided, based on the Systematic review and observational phase, will be carried out over a duration of 18 months 
Comparator Agent  no specified care bundle  standard care of management 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All neonates admitted in the neonatal intensive care unit(level2 and 3) 
 
ExclusionCriteria 
Details  Suspected or proven neonatal sepsis at time of admission
Infection within 48 hours of life
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rates of the Late onset neonatal sepsis episodes(culture proven or probable sepsis treated with seven days of antibiotics) that occurs after 72 hours of birth  at 7 days of admission to neonatal intensive care unit 
 
Secondary Outcome  
Outcome  TimePoints 
Factors influencing sustainability of the infection reduction practices by the care providers  7days of admission of newborn to the unit 
 
Target Sample Size   Total Sample Size="1347"
Sample Size from India="1347" 
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)   08/09/2025 
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="3"
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   Neonatal infection in a neonatal intensive care unit is a major challenge for the healthcare professionals, as infections are the leading cause of neonatal morbidity and mortality, apart from prematurity. 

The hypothesis of the study is that a customized neonatal infection reduction bundle can reduce late-onset neonatal sepsis in a sustained manner amongst neonates admitted to the NICU.

The study is designed to develop a neonatal infection reduction care bundle based on the analysis of the observational period and systematic review of the interventional studies done for late-onset neonatal sepsis reduction in neonates admitted to the neonatal intensive care unit. Also, a qualitative study will be conducted to look into the factors influencing the sustainability of infection reduction practices among the healthcare providers working in the neonatal intensive care unit. These factors will be looked into while devising the care bundle and addressed during the implementation of the neonatal infection reduction bundle in the unit. The neonatal infection reduction care bundle devised will be implemented over a period of three months and there after continued in the unit. During this phase multiple iterative steps will be taken to ensure compliance to the bundle, using the Plan-Do-Study-Act cycles.The impact of the bundle will be assessed by the reduction in the late-onset sepsis rates using the interrupted time series chart(post interventional phase).
 
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