| CTRI Number |
CTRI/2025/01/079530 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effectiveness of high doses versus low dose of caffeine given before removing breathing tubes in newborns on ventilators to see which helps them breathe on their better own. |
|
Scientific Title of Study
|
Efficacy of Pre-extubation High Dose vs Low Dose Caffeine Administration For Success of Weaning in Mechanically Ventilated Newborns - A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yusuf Khairullah |
| Designation |
Junior Resident |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8866937528 |
| Fax |
|
| Email |
yusufk2152@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali Edbor |
| Designation |
Professor |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9822470808 |
| Fax |
|
| Email |
dranjaliedbor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yusuf Khairullah |
| Designation |
Junior Resident |
| Affiliation |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital |
| Address |
N. K. P. Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna Road, Nagpur 440016, Maharashtra, INDIA.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8866937528 |
| Fax |
|
| Email |
yusufk2152@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute Of Medical Sciences and Research Centre And Lata Mangeshkar Hospital, Digdoh, Hingna, Nagpur 440016, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Yusuf Khairullah |
| Address |
401, Himalaya Building, Lata Mangeshkar Hospital, Digdoh, Hingna, Nagpur - 440016, Maharashtra, India. |
| 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 |
| Yusuf Khairullah |
NKP. Salve Institute of Medial Sciences & Research Centre and Lata Mangeshkar Hospital |
Neonatal Intensive Care Unit, Department of Paediatrics
Nagpur
MAHARASHTRA |
8866937528
yusufk2152@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NKP Salve Institute of Medial Sciences & Research Centre and Lata Mangeshkar Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Efficacy of Pre - Extubation High Dose v/s low dose Caffeine Administration for Success of Weaning in Mechanically Ventilated Newborns - A Randomized Controlled Trial |
The comparator agent involves administering a low-dose caffeine (5 mg/kg) to mechanically ventilated newborns 6 hours before extubation to assess its impact on the success of extubation and weaning. The study compares high dose and low dose to determine the most effective regimen for improving respiratory outcomes |
| Intervention |
Efficacy of Pre - Extubation High Dose v/s low dose Caffeine Administration for Success of Weaning in Mechanically Ventilated Newborns - A Randomized Controlled Trial |
The intervention agent involves administering a high-dose caffeine (20 mg/kg) to mechanically ventilated newborns 6 hours before extubation to assess its impact on the success of extubation and weaning. The study compares high dose and low dose to determine the most effective regimen for improving respiratory outcomes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
All newborns admitted in the Neonatal intensive care unit.
All newborns with invasive mechanical ventilation of more than 48 hours |
|
| ExclusionCriteria |
| Details |
All healthy newborns in the Postnatal care unit are excluded.
All newborns with invasive mechanical ventilation of less than 48 hours |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare pre-extubation high and low dose caffeine administration in mechanically
ventilated newborns for success of weaning in terms of :
1. Re-intubation rates
2. Duration of non-invasive ventilation needed
|
Newborns will be assessed daily i.e every 24 hourly till they are weaned completely off non invasive ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of high-dose & low-dose caffeine administration in reducing the
duration of supplemental oxygen requirement post-extubation in mechanically ventilated
newborns.
|
Newborns will be assessed every 24 hours till they are completely weaned off oxygen. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
25/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Primary Objective - To compare pre-extubation high and low dose caffeine administration in mechanically ventilated newborns for success of weaning in terms of :
1. Re-intubation rates 2. Duration of non-invasive ventilation needed |