| CTRI Number |
CTRI/2024/11/076254 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting Continuous Positive Airway Pressure Success Using Respiratory Rate Oxygenation Index (ROX) in Neonates with Respiratory Distress Syndrome |
|
Scientific Title of Study
|
Role of ROX index in predicting CPAP effectiveness in Neonates with Respiratory Distress Syndrome |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GURDEEP SINGH DHOORIA |
| Designation |
Professor |
| Affiliation |
DAYANAND MEDICAL COLLEGE AND HOSPITAL, LUDHIANA |
| Address |
Dept of Pediatrics,
Ward number 209, second floor
Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB
141012
India |
| Phone |
09915515234 |
| Fax |
|
| Email |
gurdeep2005123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mridul |
| Designation |
PG student |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Dept of Pediatrics,
Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB
141012
India |
| Phone |
09915515234 |
| Fax |
|
| Email |
mkaileshwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mridul |
| Designation |
PG student |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Dept of Pediatrics,
Ward Number 209, second floor
Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB
141012
India |
| Phone |
09915515234 |
| Fax |
|
| Email |
mkaileshwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical college and Hospital, Tagore Nagar, Ludhiana, Punjab, India PIN 141012 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical college and Hospital Ludhiana |
| Address |
Dayanand Medical college and Hospital, Tagore nagar, Ludhiana, Punjab, India. Pin 141012 |
| 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 Gurdeep S Dhooria |
Dayanand Medical College and Hospital, Ludhiana |
Dept of Pediatrics,
Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB |
09915515234
gurdeep2005123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Premature babies
Respiratory distress syndrome
requiring CPAP |
|
| ExclusionCriteria |
| Details |
Term neonates
Neonates requiring hospital stay of less than 24 hours
Neonates having congenital malformations like trachea oesophageal fistula, diaphragmatic hernia etc and complex congenital heart diseases.
Outborn neonates.
Neonates intubated immediately and put on mechanical ventilation in labour room.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To predict need for Surfactant therapy
|
Outcome will be assessed/estimated i.e. at baseline, 12 hours, 24 hours, 48 hours, and 72 hours after birth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To predict the need for Mechanical ventilation in neonates using ROX index.
To predict the duration of hospital stay required .
To predict the duration of CPAP support required.
|
Outcome will be assessed/estimated i.e. at baseline, 12 hours, 24 hours, 48 hours, & 72 hours after birth |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
15/11/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gurdeep2005123@gmail.com].
- For how long will this data be available start date provided 10-01-2026 and end date provided 10-01-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Respiratory
Distress occurs among 4-7% of all neonates and is the most common reason
for 30-40% of admissions in the Neonatal
intensive care unit. It is more common among preterm (30%) and post term (21%)
than term neonates.
CPAP
is a non-invasive type of respiratory support which can be delivered without
endotracheal intubation though classical mechanical ventilators can also
provide CPAP. It works by providing a continuous level of positive pressure to
the airways which distends the lungs, overcomes collapse and improves
ventilation.
ROX
index has not been validated in neonates with RDS earlier so it will help to predict CPAP failure in neonates
with RDS using simple and easily accessible clinical parameters like SpO2,
FiO2, and Respiratory Rate to help minimise morbidity and mortality in preterm
neonates by doing early intervention in the form of giving surfactant therapy
and mechanical ventilation. Hence the need for the study. |