| 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
|
|
|
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
|
|
|
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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