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CTRI Number  CTRI/2026/02/104746 [Registered on: 25/02/2026] Trial Registered Prospectively
Last Modified On: 24/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Single Arm Study 
Public Title of Study   Reducing blood infections in newborn babies in the hospital 
Scientific Title of Study   A Point of Care Quality Improvement Study to decrease incidence of Central Line Associated Bloodstream Infections and Late Onset Sepsis in neonates 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tejaswini Pathak 
Designation  Senior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Neonatology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9801652388  
Fax    
Email  tejaswini.pathak95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sheila S. Mathai 
Designation  Professor and Head of Department 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Neonatology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9930954139  
Fax    
Email  sheila.mathai@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Tejaswini Pathak 
Designation  Senior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Neonatology, Kasturba Medical College, Manipal


KARNATAKA
576104
India 
Phone  9801652388  
Fax    
Email  tejaswini.pathak95@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, Kasturba Medical College, Manipal-576104 Karnataka 
 
Primary Sponsor  
Name  Tejaswini Pathak Self 
Address  Department of Neonatology, Kasturba medical college 
Type of Sponsor  Other [Self] 
 
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 Tejaswini Pathak  Neonatal intensive care unit  Department of Neonatology, KMC Manipal
Udupi
KARNATAKA 
9801652388

tejaswini.pathak95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and kasturba hospital 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 
Comparator Agent  Baselines process rates  Baseline process rates will be compared with process rates at the end of sustenance phase 
Intervention  Quality improvement study  Checklists for hand hygiene, Aseptic no touch techniques and CLABSI bundles training programs focus group discussions 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  all neonates admitted to NICU for more than 48 hours during study period 
 
ExclusionCriteria 
Details  congenital infections or proven vertically transmitted infections
babies with congenital anomalies that increase chances of infections like primary immunodeficiency disorders open neural tube defects cleft palate tracheoesophageal fistula etc
neonates with proven or clinical sepsis at admission 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
primary outcome-process indicators -compliance rate of hand hygiene,ANTT and CLABSI bundle measured in percentage  Checked at the end of baseline phase-2 months
Intervention phase-3months
sustenance and monitoring phase-8-10 months 
 
Secondary Outcome  
Outcome  TimePoints 
Central line associated bloodstream infections rate
Late onset sepsis rate-
1. culture positive sepsis
2.clinical sepsis 
Clabsi rate- 1000 clabsi days
Culture positive sepsis- admitted for more than 48 hours
clinical sepsis-admitted for than 48 hours
 
 
Target Sample Size   Total Sample Size="856"
Sample Size from India="856" 
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   Phase 1 
Date of First Enrollment (India)   07/03/2026 
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="5"
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  

This study is a point of care quality improvement initiative conducted in a level 3b neonatal intensive care unit with the aim of reducing infection rates particularly central line associated bloodstream infection and late onset sepsis. The study will be carried out in three phases baseline implementation and sustenance. During the baseline phase current practices related to hand hygiene aseptic non touch technique and central line care will be assessed through direct observation and focus group discussion to identify gaps and root causes of infection. In the implementation phase plan do study act cycles will be used to introduce targeted changes such as staff training reinforcement of infection prevention bundles and use of checklists. Process indicators will be monitored regularly using run charts to evaluate improvement.In the sustenance phase the successful interventions will be integrated into routine care and ongoing monitoring will be done through periodic observations. Outcome measures including infection rates will be calculated and compared with baseline data.The study involves no additional interventions beyond standard care and is expected to improve patient safety by strengthening adherence to infection prevention practices in the NICU.

 
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