| CTRI Number |
CTRI/2018/10/016130 [Registered on: 24/10/2018] Trial Registered Prospectively |
| Last Modified On: |
23/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
To study the breathing machine related lung disease in Neonatal Intensive Care Unit |
|
Scientific Title of Study
|
Implementation and Assessment of Ventilator Associated Pneumonia bundle strategy to prevent ventilator associated pneumonia in Neonatal Intensive Care Unit
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahin Banu |
| Designation |
Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy
School Of Allied Health Sciences
MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
rahin.banu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tisha Ann Skariah |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy
School Of Allied Health Sciences
MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
tisha_skariah@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahin Banu |
| Designation |
Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Respiratory Therapy
School Of Allied Health Sciences
MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
rahin.banu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital
Madhav Nagar
Manipal
Karnataka 576104
Manipal |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Rahin Banu |
Kasturba Hospital |
NICU, Kasturba Hospital, Madhava Nagar, Opposite Tiger Circle, Manipal
Udupi
KARNATAKA |
8884802912
rahin.banu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Z00-Z99 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Prevention of VAP |
Education session:
Technique:Power point presentation on VAP
Duration: 30 minutes session
One session in every month (during the phase 2 of the study)
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
All neonates admitted to NICU during study period and utilized mechanical ventilation for ≥ 48 hours |
|
| ExclusionCriteria |
| Details |
-Neonates who will be empirically started on antibiotics before mechanical ventilation
-Out-hospital intubations
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the incidence of VAP pre and post implementation of VAPB
|
Before and after implementation of VAP Bundle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of each bundle component on the VAP incidence
The correlation between full adherence to the VAPB and VAP incidence
|
Before and after implementation of VAP bundle |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
02/11/2018 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To reduce the incidence of VAP and reduce the associated morbidity and mortality. Aim of the study is to Implement and Assess ventilator associated pneumonia in Neonatal intensive care unit. The study will be conducted between october 2018- March 2019. All neonates admitted to NICU during study period and utilized mechanical ventilation for ≥ 48 hours. It is a time dependent study with three phases, Phase 1, Phase 2 and Phase 3 wherein Phase 1 will assessed to check the incidence rate of VAP in mechanically ventilated newborns, to check the adherence of VAP bundle and debriefing if any errors in practice, The observations will be documented by the primary investigator. In phase 2, “VAP prevention bundle will be tailored according to common errors found out in Phase I and include common evidence-based practices recommended by previous studies and agencies. We will be performing education session to discuss evidences about the pathogenesis, risk factors, danger of VAP and its sequel and the need for VAP bundle. Training and re-training campaigns will be performed for each VAP bundle’s item. Phase 3 is a post VAP bundle implementation phase, re-evaluation of VAP rate to assess the efficacy of the infection control bundle.
|