| CTRI Number |
CTRI/2024/02/062501 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Control Trial to see the effect of omission of stimulation from initial steps of resuscitation . |
|
Scientific Title of Study
|
"Comparison of the clinical outcomes of newborns after omission STIMULATION from initial steps of resuscitation VS Standard neonatal resuscitation program : A Randomized Control 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 |
Mudrika Gupta |
| Designation |
Junior resident 3 |
| Affiliation |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Room number 6 1st floor
Department of Pediatrics
GSVM medical college Kanpur
Department of Pediatrics
GSVM medical college Kanpur
Agra
UTTAR PRADESH
282002
India |
| Phone |
8077113370 |
| Fax |
|
| Email |
mudrikagupta138@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yashwant Kumar Rao |
| Designation |
Professor |
| Affiliation |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Room no. 6 1st floor
Department of Pediatrics
GSVM Medical college, Kanpur
Department of Pediatrics
GSVM Medical College Kanpur
Kanpur Nagar
UTTAR PRADESH
282002
India |
| Phone |
9919080807 |
| Fax |
|
| Email |
ykraoneo@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Yashwant Kumar Rao |
| Designation |
Professor and Ex Head of the department |
| Affiliation |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Room number 6 first floor
Department of pediatrics
GSVM Medical college Kanpur
Gsvm medical college Kanpur
Kanpur Nagar
UTTAR PRADESH
282002
India |
| Phone |
9919080807 |
| Fax |
|
| Email |
ykraoneo@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ganesh Shankar Vidyarthi medical College Kanpur |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
NA |
| Type of Sponsor |
Other [none] |
|
|
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 Mudrika Gupta |
GSVM Medical college Kanpur |
Room no. 6 first floor
Department of Pediatrics
GSVM Medical college Kanpur
Kanpur Nagar
UTTAR PRADESH |
8077113370
mudrikagupta138@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee(For Biomedical Health and Research) Room no.125, GSVM Medical College Kanpur |
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 |
follow the basic NRP protocol |
If a baby is delivered and does not cry after birth we will proceed with the NRP protocol and give stimulation. |
| Intervention |
Omission of Stimulation
from Initial steps of resuscitation" |
we are going to omit the step of stimulation from initial steps by giving positive pressure ventilation to the patient directly to the child who does not cry immediately after birth and seeing the long term outcome. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Not breathing or crying at birth |
|
| ExclusionCriteria |
| Details |
Major congenital heart, CNS or respiratory system anomaly
Not giving consent |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
duration of hospital stay
development of long term neurological deficits |
baseline
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Normal healthy baby
2. Hypoxic Ischemic Encephalopathy stages 1,2,3
3. Death
4. Any other complication of hypoxia.
|
7days after birth
1 month after birth |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="10" |
|
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 - NO
|
|
Brief Summary
|
The goals of neonatal resuscitation are to prevent the morbidity and mortality associated with hypoxic ischemic tissue injury and also to re establish adequate spontaneous respiration and cardiac output.
AIM is to simplify the NRP protocol by omission of stimulation from Initial steps of resuscitation. and find the outcome of the newborn.
|