| CTRI Number |
CTRI/2026/03/106276 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of pneumonia in newborn babies on ventilators in a rural tertiary hospital |
|
Scientific Title of Study
|
Clinical Profile of Ventilator Associated Pneumonia in Neonates in Tertiary Care Rural Hospital |
| 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 Unnati Jaiswal |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Pediatrics, 2nd Floor, AVBRH Building,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8319069521 |
| Fax |
|
| Email |
unnati.jaiswal212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Varma |
| Designation |
Proffessor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Pediatrics, 2nd Floor, AVBRH Building,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860500063 |
| Fax |
|
| Email |
avarma2055@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Varma |
| Designation |
Proffessor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Pediatrics, 2nd Floor, AVBRH Building,
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860500063 |
| Fax |
|
| Email |
avarma2055@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Wardha,Maharashtra, India, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Unnati Jaiswal |
Acharya Vinoba Bhave Rural Hospital |
Department of Pediatrics, 2nd Floor, AVBRH Building,
Sawangi Meghe
Wardha
MAHARASHTRA |
8319069521
unnati.jaiswal212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J42||Unspecified chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
1. Neonates admitted in NICU
2. Having risk of ventilator associated pneumonia |
|
| ExclusionCriteria |
| Details |
1. Refusal of consent
2. Patients with NICU stay less than 48 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of most common microorganisms for VAP. |
Assessment will be done at 2 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/04/2026 |
| 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="2"
Months="6"
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
|
Ventilator associated pneumonia is a serious nosocomial infection among neonates admitted in NICU. This study will be conducted in NICU of dept of pediatrics, AVBRH, Wardha to find incidences of VAP and help to revise current antibiotic policy. This will be a cross sectional study and a total of 70 neonates will be assessed. |