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CTRI Number  CTRI/2025/02/080646 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 05/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Quality Improvement 
Study Design  Other 
Public Title of Study   To decrease central line associated infection in neonates in NICU by quality improvement  
Scientific Title of Study   Reduction in Central Line Associated Blood Stream Infection (CLABSI) rate in a tertiary level Neonatal Intensive Care Unit through a Quality Improvement Initiative.  
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 Saikat Patra  
Designation  Associate Professor  
Affiliation  Swami rama himalayan university  
Address  Department of Neonatology HIMS SRHU Swami Ram Nagar Jolly Grant Dehradun 248016 Uttarakhand India

Dehradun
UTTARANCHAL
248016
India 
Phone  9780317739  
Fax    
Email  dr.saikatpatra@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Jaybhaye Deepak Khushalrao  
Designation  senior resident  
Affiliation  Swami rama himalayan university  
Address  Department of Neonatology Himalayan Institute of Medical Sciences Swami Ram Nagar Jolly Dehradun 248016 Uttarakhand India

Dehradun
UTTARANCHAL
248016
India 
Phone  9284552683  
Fax    
Email  djaybhaye7@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Jaybhaye Deepak Khushalrao  
Designation  senior resident  
Affiliation  Swami rama himalayan university  
Address  Department of Neonatology Himalayan Institute of Medical Sciences Swami Ram Nagar Jolly Dehradun 248016 Uttarakhand India

Dehradun
UTTARANCHAL
248016
India 
Phone  9284552683  
Fax    
Email  djaybhaye7@gmail.com   
 
Source of Monetary or Material Support  
HIMS SWAMI RAMA HIMALAYAN UNIVERSITY Swami Ram Nagar Jolly Grant Dehradun 248016 Uttarakhand India 
 
Primary Sponsor  
Name  swami rama himalayan university  
Address  SWAMI RAMA HIMALAYAN UNIVERSITY Swami Ram Nagar Jolly Grant Dehradun 248016 Uttarakhand India 
Type of Sponsor  Research institution and hospital 
 
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 SAIKAT PATRA  Himalayan Institute of Medical Sciences   NICU-Ward No.110,First Floor Hospital Building, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Swami Ram Nagar,248140 Dehradun, Uttaranchal
Dehradun
UTTARANCHAL 
9780317739

dr.saikatpatra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Swami Rama Himalayan University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil 
Comparator Agent  Nil   Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All infants in whom central line is placed in NICU. 
 
ExclusionCriteria 
Details  All infants with in situ central line at the time of admission to NICU 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Central line associated blood stream infection- CLABSI rate in neonatal intensive care unit   18 month after initiation of study  
 
Secondary Outcome  
Outcome  TimePoints 
Sepsis rate in neonatal intensive care unit  18 month after initiation of study  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="237" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/02/2025 
Date of Study Completion (India) 31/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

 

·       Reduction in Central Line-associated Bloodstream Infections (CLABSI) in neonates admitted to NICU from 25 /1000 line days by 25% at a tertiary care hospital over a period of six months and sustain over nine months.

·       This prospective QI study was conducted over 16 months in a tertiary NICU. A multidisciplinary team implemented sequential interventions using the Point-of-Care Quality Improvement (POCQI) methodology and Plan–Do–Study–Act (PDSA) cycles. Interventions included improvement in hand hygiene, central line maintenance (scrub-the-hub), and intravenous fluid preparation using aseptic non-touch technique (ANTT) under laminar airflow. Outcome measures were CLABSI rate per 1000 line days and blood culture positivity. Process indicators included hand hygiene and bundle compliance. Data were analysed using run charts.

·       A total of 237 neonates were included. Baseline CLABSI rate was 25/1000 line days, which reduced to 11.4/1000 line days (54.4% reduction). During the sustenance phase, rates remained below baseline (9–11.4/1000 line days). Hand hygiene compliance improved from 0% to ~70%, and scrub-the-hub compliance to 62%. Blood culture positivity decreased from 36.1% to 16.3%, and antibiotic utilization ratio reduced from 1.67 to 0.88. Improvements were sustained despite operational challenges.

·       Structured, low-cost QI interventions using POCQI methodology significantly reduced CLABSI rates and improved infection control practices. Sustained reduction requires continuous monitoring, team engagement, and reinforcement of best practices.

CLABSI rates reduced from 25 to 11.4 per 1000 central line days (54.4% reduction) at our tertiary care hospital over a period of 13 months and sustained over 5 months. Improvement in knowledge, attitude and practice of hand hygiene, adherence to proper central line care bundle, and preparing IV fluids by aseptic non touch technique (ANTT) paid rich dividend in reduction of CLABSI. Reduction in CLABSI led to overall reduction of infection and antibiotic utilization. Blood culture positivity reduced from 36.1% to 16.3 %, with significant improvement observed in inborn neonates from 29.6% to 11.6%. Antibiotic utilization ratio (AUR) reduced from 1.67 to 0.88 with significant improvement observed in inborn neonates from 1.76 to 0.66. In conclusion, simple and low-cost interventions using POCQI approach led to significant reduction in CLABSI in our NICU. Regular monitoring, feedback, and teamwork were essential to sustain the changes.


 
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