| CTRI Number |
CTRI/2025/09/094959 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical efficacy of t piece resuscitator versus selfinflating bag for resuscitation in preterm neonates requiring positive pressure ventilation at birth. |
|
Scientific Title of Study
|
Clinical efficacy of t piece resuscitator versus selfinflating bag for resuscitation in preterm neonates requiring positive pressure ventilation at birth: 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 Ruchika Bhatnagar |
| Designation |
Associate Professor |
| Affiliation |
Government Institute of Medical Sciences (GIMS) |
| Address |
Department Pediatrics
Room no. 19 Ground floor
GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
891865066 |
| Fax |
|
| Email |
ruchu.bhatnagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurangi Jaiswal |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department Pediatrics
Room no. 19 Ground floor
GIMS Hospital
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
6388431180 |
| Fax |
|
| Email |
gaurangijaiswal08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurangi Jaiswal |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences |
| Address |
Department Pediatrics
Room no. 19 Ground floor
GIMS Hospital
UTTAR PRADESH
201310
India |
| Phone |
6388431180 |
| Fax |
|
| Email |
gaurangijaiswal08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS)
kasna, greater Noida
Gautam buddha Nagar
Uttar Pradesh Pin-201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences Greater Noida |
| Address |
kasna, greater Noida Gautam buddha Nagar Uttar Pradesh Pin-201310 |
| Type of Sponsor |
Government 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 Gaurangi Jaiswal |
Government Institute of Medical Sciences (GIMS) |
Room 19, Department of Pediatrics
Gautam Buddha Nagar
UTTAR PRADESH |
6388431180
gaurangijaiswal08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Self Inflating bag |
As per NRP protocol positive pressure ventilation will be provided till the end of NICU Stay. |
| Intervention |
T piece resuscitator |
As per NRP protocol positive pressure ventilation will be provided till the end of NICU Stay |
|
|
Inclusion Criteria
|
| Age From |
0.50 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Neonates born in this tertiary care irrespective of mode of delivery will be eligible for enrolment if they fulfil the following inclusion criteria:
Neonates with gestational age of less than
1. not breathing apneic or gasping.
2. Neonates with Heart Rate less than 100 beats per minute after completion of initial steps of neonatal
resuscitation. |
|
| ExclusionCriteria |
| Details |
Neonates with any of the following conditions will be excluded:
1.Major congenital malformation for example congenital diaphragmatic hernia, central cleft lip, Cleft Palate
2.Major CNS malformations For example Meningomyelocele
3. Twin gestation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Delivery room intubation rate |
At the time of enrollment day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of NICU stay
-Need of surfactant
-Neonates developing bronchopulmonary dysplasia at 36 weeks |
From Base line to till end of the NICU stay |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
16/10/2025 |
| 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) |
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
|
A systematic review conducted by Roehr et al (2021) 5 on comparison of effectiveness of T
piece vs SIB in neonatal care. in pediatric journal by Roehr and Davis had a scoping review that
compared the effectiveness of T-piece resuscitator (TPR) and self-inflating bag (SIB) in neonatal
care. Analyzing four key studies with 2889 neonates, the review found no significant difference in
overall survival or air leak incidence between TPR and SIB groups. However, TPR showed
potential benefits in preterm infants, including lower delivery room intubation rates, reduced
bronchopulmonary dysplasia, and higher survival rates. While randomized controlled trials didn’t
demonstrate statistically significant superiority of TPR, the consistent trend favoring TPR,
especially in preterm infants, suggests potential clinical benefits. The review highlights the need for
further research to confirm these findings and explore the advantages of TPR in specific neonatal
populations. |