| CTRI Number |
CTRI/2026/01/100920 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| 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
|
Use of different levels of pressure to assist breathing on oxygen levels in tiny babies at birth |
|
Scientific Title of Study
|
Effect of Different Levels of Positive End Expiratory Pressure on Oxygen Saturation in Preterm Neonates at Birth: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMS/IEC/26/13, version 1, dated 07/01/2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriparna Basu |
| Designation |
Professor & Head, Department of Neonatology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016123, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9935340260 |
| Fax |
|
| Email |
sriparna.neonat@aiimsrishikesh.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakshita Jonwal |
| Designation |
Academic Senior Resident (DM Neonatology) |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016121, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9460436995 |
| Fax |
|
| Email |
me.rakshita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sriparna Basu |
| Designation |
Professor & Head, Department of Neonatology |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
Room No.016123, Block A, Medical College Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9935340260 |
| Fax |
|
| Email |
sriparna.neonat@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Rishikesh, Virbhadra Marg, Pashulok, Dehradun, Uttaranchal - 249203, India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences, Rishikesh Virbhadra Road,Pashulok, District- Dehradun, Uttaranchal - 249203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sriparna Basu |
Room No.016113, Block A, Medical College Building, Department of Pediatrics, All IndiaInstitute of Medical Sciences, Rishikesh Dehradun, UTTARANCHAL 249203, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sriparna Basu |
All India Institute of Medical Sciences, Rishikesh |
Labor Room Complex and Obstetric Operation Theater Level 3,B Block, Hospital Building, Department of Gyne and Obstetrics and Labor Room Nursery and Neonatal Intensive Care Unit Level 3, B Block, Hospital Building, Department of Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL |
9935340260
sriparna.neonat@aiimsrishikesh.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P289||Respiratory condition of newborn,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
During neonatal resuscitation at birth, providing a positive end expiratory pressure of 5-6 cm of water during respiratory stabilization |
In neonates requiring positive pressure ventilation or delivery room continuous positive airway pressure after initial steps at birth, a positive end expiratory pressure of 5-6 cm of water will be provided with a T-piece resuscitator and appropriate size face mask till the respiratory distress of the neonate is settled in delivery room or the neonate is shifted to NICU for further respiratory management if respiratory distress persists |
| Intervention |
During neonatal resuscitation at birth, providing a positive end expiratory pressure of 7-8 cm of water during respiratory stabilization |
In neonates requiring positive pressure ventilation or delivery room continuous positive airway pressure after initial steps at birth, a positive end expiratory pressure of 7-8 cm of water will be provided with a T-piece resuscitator and appropriate size face mask till the respiratory distress of the neonate is settled in delivery room or the neonate is shifted to NICU for further respiratory management if respiratory distress persists |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Inborn preterm neonates with gestational age less than 34 weeks requiring delivery room respiratory support, either positive pressure ventilation (PPV) or delivery room continuous positive airway pressure (CPAP) as per American Heart Association Neonatal Resuscitation Program guidelines |
|
| ExclusionCriteria |
| Details |
1. Major congenital anomalies
2. Inability to obtain parental consent
3. Parental decision - not to resuscitate |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peripheral oxygen saturation |
At 5 minutes of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to achieve heart rate more than 100 per minute
2. Time to achieve peripheral oxygen saturation more than 80% & more than 85%
3. Duration of positive pressure ventilation
4. Need for delivery room intubation, chest compression, & medications
5. Minute-specific heart rate, peripheral oxygen saturation, & fraction of inspired oxygen at different time intervals
6. APGAR score at 5 minutes
7. Lung ultrasound score at NICU admission
8. Incidence of pneumothorax
9. Cerebral regional oxygen saturation at 1 hour
10. Need for surfactant
11. Need & duration of respiratory support in delivery room & in NICU
12. Duration of supplemental oxygen
13. Duration of hospital stay
14. Final outcome
15. Hammersmith Neonatal Neurological Examination score at discharge
16. Incidence of adverse events during hospital stay
|
At baseline, subsequently weekly during hospital stay, & at discharge |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
23/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sriparna.neonat@aiimsrishikesh.edu.in].
- For how long will this data be available start date provided 01-01-2029 and end date provided 01-01-2032?
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
|
The present RCT compares two different PEEP strategies. |