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CTRI Number  CTRI/2025/02/080646 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
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)= "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)   25/02/2025 
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="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

 all neonates admitted in NICU in whom central line is place in NICU will be included in study. Observational study using WHO Point of Care Quality Improvement Model, using Plan–Do–Study–Act (PDSA) cycles approach. The duration of the QI is a 3 months baseline phase followed by 6 months of implementation which will be undertaken in the form of Plan-Do-Study-Act (P-D-S-A) cycles. The sustenance phase is for 9 months.  Root cause analysis will be done by FISH BONE ANALYSIS and Process Flowchart for identifying the possible causes of CLABSI in the unit. This will be followed by PDSA cycles for improving the process of care and developing a care bundle. Data will be plotted on RUN charts. A QI team will be formed involving one NICU consultant, one microbiologist, NICU in-charge nursing staff, 1 NICU senior resident, 1 NICU infection control sister, 1 quality control sister. The study will be conducted in 3 phases. 1) Pre-implementation phase - All patients with central line in place for more than 48 hours, with day of line placement as day 1, will be enrolled and followed-up until either transfer from NICU to step-down unit, discharge or death. Compliance during CL insertion and maintenance will be observed. Hand hygiene compliance will be observed. 2 Implementation phase - The educational sessions of nursing staff and resident doctors will be done which will include definition of CLABSI, preventive measures and explanation of project bundles, procedures and forms. Compliance with insertion and improving of processes will be done using PDSA. Changes will be either adopted or abandoned as study will progress. Staff meetings will be held to discuss the non-compliances. One PDSA cycle for 2-4 weeks will be done. Changes will be done in strategies depending on results at the end of each cycle. Accordingly multiple PDSA cycles will be done over the period of 6 months. 3) Sustenance phase- For next 9 month period, all patient with CL in place for >48 hours with day of line placement as day 1, will be enrolled The following data will be recorded for all patients: Data regarding GA, CA, birth wt. and current wt., place of birth, duration of NICU stay, brief clinical history along with date, time and reason for insertion and removal will be recorded. Duration for each line will also be recorded. Line day at which CLABSI is confirmed will also be noted. All data will be collected by a NICU team. The process indicators will be based on hand hygiene (audits per month) and central line care audits (audits per month). Outcome measures and process indicators CLABSI /1000 line days BSI /1000 patient days Line days/1000 patient days


 
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