| 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
|
|
|
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
|
|
|
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. |