| 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
|
|
|
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)= "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.
|