| CTRI Number |
CTRI/2019/03/018240 [Registered on: 25/03/2019] Trial Registered Prospectively |
| Last Modified On: |
24/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Practices to decrease rate of hospital acquired infection in babies admitted in NICU |
|
Scientific Title of Study
|
Quality initiatives to decrease the incidence of hospital acquired bloodstream infection among babies in NICU setting |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekansh Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics, Kasturba medical college, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9458704264 |
| Fax |
|
| Email |
ekanshagarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Leslie Lewis |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics, Kasturba medical college, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449208476 |
| Fax |
|
| Email |
leslie.lewis@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ekansh Agarwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics, Kasturba medical college, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9458704264 |
| Fax |
|
| Email |
ekanshagarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, manipal |
|
|
Primary Sponsor
|
| Name |
Leslie lewis |
| Address |
Department of pediatrics, Kasturba Medical college, Manipal |
| 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 |
| Ekansh agarwal |
Neonatal Intensive Care Unit (NICU), Department of Paediatrics, Kasturba Hospital, Manipal |
Department of Pediatrics, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9458704264
ekanshagarwal@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: P369||Bacterial sepsis of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Hand Hygiene training and awareness among health care workers.
2. Central line handling checklist
3. Display Board.
4. Family education |
1. Hand hygiene training will be provided to all health care workers in frequency if 4-5 times depending upon the availability, and hand hygiene rates will be monitored for 6 months.
2. Central line handling check list will be displayed bed side for 6 months.
3. A display board will be put in the NICU where it is visible to all, which will display the hand hygiene rates, current sepsis rates, days since last sepsis, to improve compliance.
4. Family education to mothers caring the extremely low birth weight babies admitted for long duration by making a leaflet depicting the hygiene mother needs to maintain in local language. Will be applied for 6 months |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
All Babies admitted in NICU for more than 3 days of life. |
|
| ExclusionCriteria |
| Details |
• Babies with positive blood culture within 3 days of admission. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of blood culture positive hospital acquired infection after 6 months |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of blood culture positive hospital acquired infection after every month |
1 month |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
01/07/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
1. Title of the project : “ Quality initiatives to decrease the incidence of hospital acquired bloodstream infection among babies in NICU setting†2. Type of Study : Multifaced
study 3. Aims & objectives : AIM- To decrease the incidence of hospital acquired bloodstream infection among babies in NICU setting. Objectives- 1.
Identify the Incidence of late onset
infection in NICU (2017-18)
2.
List the major risk factors for
nosocomial sepsis.
3.
Describe practices that can reduce the
risk of nosocomial infections
4.
Implementation and assessment of
effectiveness of infection control bundles a) Inclusion criteria : • Quality initiatives will
be implemented on all the health care workers working in the NICU during the
study period.
•
All Babies admitted in NICU for more than 3 days of life will be observed
for blood stream infection. Exclusion criteria : • Babies with positive blood culture within 3 days of admission. Detailed description of procedure / processes : Quality bundles will be formed which will include: • Hand hygiene • Line insertion Checklists • Improving infection awareness • Family education and awareness. |