| CTRI Number |
CTRI/2025/01/079244 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare two methods of giving artificial breaths namely self-inflating bag and T- piece resuscitator, to a newborn baby who do not cry at birth |
|
Scientific Title of Study
|
Use of self-inflating bag versus T piece
resuscitator for resuscitation at the time of
birth in preterm neonates—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 |
Dr Sandeep Avasarala |
| Designation |
DM Resident, Neonatology |
| Affiliation |
NIMS University, Jaipur, Rajasthan |
| Address |
1st floor, Department of Neonatology, NIMS Hospital and Medical College, Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
09784011957 |
| Fax |
|
| Email |
avasarala.88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjana Kumar |
| Designation |
Associate Professor |
| Affiliation |
NIMS University, Jaipur, Rajasthan |
| Address |
1st floor, Department of Neonatology, NIMS Hospital and Medical College,Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
7073077130 |
| Fax |
|
| Email |
gunjanakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjana Kumar |
| Designation |
Associate Professor |
| Affiliation |
NIMS University, Jaipur, Rajasthan |
| Address |
1st floor, Department of Neonatology, NIMS Hospital and Medical College,Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Jaipur
RAJASTHAN
303121
India |
| Phone |
7073077130 |
| Fax |
|
| Email |
gunjanakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF NEONATOLOGY NIMS HOSPITAL, JAIPUR , RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Dr Sandeep Avasarala |
| Address |
1st floor, Department of Neonatology, Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121 |
| Type of Sponsor |
Other [] |
|
|
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 Jai Krishan Mittal |
Department of Neonatology, NIMS Hospital, NIMS University, Jaipur, Rajasthan |
Shobha Nagar, Jaipur-Delhi Highway (NH-11C), Jaipur, Rajasthan 303121
Jaipur
RAJASTHAN |
9784011957
avasarala.88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NIMS University Rajasthan Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P914||Neonatal cerebral depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self-inflating Bag |
It is a compressible, self-inflating, non-rebreathing silicon bag, which has an inlet through which air and additional O2 is supplied and an outlet through this can be transferred to the patient. The gas enters in the self-expanding bag through one way valve which restricts the flow back from the inlet. When the bag is compressed, the air is pushed forward through the mask in the pharynx or throat which in turn leads to wind pipe and then in the lungs, hence assisting in artificial ventilation |
| Intervention |
T-piece resuscitator |
The T-piece resuscitator, on the other hand, is designed to deliver more controlled and consistent
ventilation pressures (both PIP and PEEP) |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
All the following should be fulfilled for enrolment:
a) Inborn neonates (delivered at NIMS hospital, Jaipur)
b) Gestational age 25 to 34 weeks
c) Neonates that have not cried after birth and after initial steps require positive pressure
ventilation due to apnea/gasping/heart rate less than 100 beats per minute
d) Delivered vaginally, through Cesarean or via assisted delivery |
|
| ExclusionCriteria |
| Details |
Any one of the following
a) Major congenital malformation (antenatally diagnosed or visible at birth)
b) Refusal of consent by parents |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for delivery room intubation |
Discharge/ LAMA or Death of baby |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Several clinical outcomes will be compared in both groups such as :
i. Duration of PPV
ii. Time to spontaneous breathing
iii. Time to achieve HR ≥100 bpm
iv. Saturation at 5 minutes of birth
etc. |
Discharge/ LAMA from hospital or Death |
|
|
Target Sample Size
|
Total Sample Size="136"
Sample Size from India="136"
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)
|
02/02/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
This study is a randomized, open label, parallel group
trial comparing the efficacy of T-piece resuscitator and self-inflating bag in
providing positive pressure ventilation to newborns at birth. The study will be
conducted on 136 newborns at the department of Neonatology, NIMS Hospital and
Medical College, Jaipur, India. The primary outcome measure will the be need for
delivery room intubation. The secondary outcomes The secondary outcomes will be
the comparision of clinical outcomes in
both groups such as -i. Duration of PPV, ii. Time to spontaneous breathing, iii.
Time to achieve HR ≥100 bpm , iv. Saturation at 5 minutes of birth etc.
|