| CTRI Number |
CTRI/2026/01/102015 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| 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
|
Trial of different methods of stabilizing mature newborns with breathing difficulty at birth |
|
Scientific Title of Study
|
Effect of Continuous Positive Airway Pressure versus Free Flow Oxygen on Treatment Failure during Delivery Room Stabilization in Neonates more than or equal to 35 weeks : A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIIMS/IEC/26/14 Date: 09/01/2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayank Priyadarshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No.016116, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9968856843 |
| Fax |
|
| Email |
mayank.neonat@aiimsrishikesh.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pragya Mishra |
| Designation |
Academic Senior Resident (DM Neonatology) |
| Affiliation |
AIIMS 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 |
9919427357 |
| Fax |
|
| Email |
pragyam614@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mayank Priyadarshi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Room No.016116, Block A, Medical College Building, Department of
Neonatology, All India Institute of Medical Sciences, Rishikesh
Dehradun UTTARANCHAL 249203 India |
| Phone |
9968856843 |
| Fax |
|
| Email |
mayank.neonat@aiimsrishikesh.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh, Virbhadra Road, Pashulok, District- Dehradun Uttaranchal, India - 249203 |
|
|
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 |
| Dr Mayank Priyadarshi |
Room No. 016116, Block A, Medical College Building, Department of Neonatology, All India
Institute 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 |
| Dr Mayank Priyadarshi |
All India Institute of Medical Sciences, Rishikesh |
Neonatal Intensive Care Unit, Level 3, B Block, Hospital
Building, Department of Neonatology Dehradun UTTARANCHAL |
9968856843
mayank.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: P22||Respiratory distress of newborn, (2) ICD-10 Condition: P221||Transient tachypnea of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous positive airway pressure |
T piece resuscitator (through Drager resuscitaire infant warmer connected to central gas supply of hospital) will be used for providing DR CPAP via face mask with initial settings of FiO2 of 21% (titrated as per target saturation), PEEP of 5 cm H2O (titrated up to maximum 8 cm H2O as per respiratory distress) and a flow rate of 10 L/min. Appropriate size face mask (LSR silicone mask; Laerdel, Stavanger, Norway) will be used to deliver CPAP. |
| Comparator Agent |
Free flow oxygen |
Free flow oxygen will be provided by oxygen by hood at 10 L/min and FiO2 30% which will be titrated as per target saturation. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
Neonates born at or more than 35 weeks of gestation with spontaneous breathing and HR more than 100 per min with RD at birth defined as at least one of the following signs of increased work of breathing such as Tachypnea (respiratory rate more than 60/min), Chest retractions, Not able to maintain minute-specific target saturation or more than 90% after 10 minutes of life, Nasal flaring, and Grunting.
|
|
| ExclusionCriteria |
| Details |
Neonates with major congenital malformations, Neonates requiring PPV or intubation at birth
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of treatment failure, defined as any: Need for NICU admission (persistence of RD or not able to maintain SpO2 more than 90% on room air at one hour of life), Escalation of respiratory support (on worsening of RD or FiO2 requirement more than 0.5 despite 30 minutes of intervention), or Need for PPV or intubation in the delivery room after randomization (as decided by treating team) |
One hour of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LUS score |
Within 2 hours of life |
Incidence of pneumothorax
|
24 hours of life |
| Need and duration of invasive and non-invasive respiratory support in NICU |
At hospital discharge |
Length of hospital stay
|
At hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
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 3 |
|
Date of First Enrollment (India)
|
04/02/2026 |
| 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 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 - 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 Response - Informed Consent Form
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mayank.neonat@aiimsrishikesh.edu.in].
- For how long will this data be available start date provided 30-11-2028 and end date provided 30-11-2031?
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
|
Before the delivery of a potentially eligible neonate, the
parents will be approached for consent. Eligible neonates will be enrolled
after obtaining written informed consent from the parents. Consecutively born
neonates will be screened for eligibility at birth. Resuscitation will proceed
as per NRP guidelines 2025. Neonates who require PPV or intubation at birth
will be excluded. Any neonate born at or more than 35 weeks who is
spontaneously breathing with a heart rate of at least 100 bpm but develops RD in
the DR meeting the eligibility criteria will be enrolled in the trial.
Neonates in both groups will be assessed by the treating
team for clinical condition and need for any intervention in the DR. Any
neonate with acute deterioration will be provided PPV or intubated as per NRP
guidelines. Respiratory support will be escalated (PPV in CPAP group or CPAP in
FFO group) if RD worsens or FiO2 requirement is more than 0.5 despite 30
minutes of intervention. Neonates with persistent RD or not able to maintain
SpO2 more than 90% on room air at one hour of life will be admitted to the
NICU. Neonates who improve in the DR (no signs of RD and maintaining SpO2 in
the target range) will be shifted to mother-side for ongoing monitoring and
routine newborn care.
Irrespective of the need for NICU admission, all neonates
will undergo a LUS examination at 2 hours of life for quantitative LUS scoring
and any evidence of pneumothorax. LUS clips will be recorded and assessed by an
independent assessor who will be blinded to allocated intervention. LUS scoring
will be done by the method described by Brat et al. During the same LUS
examination, pneumothorax will be diagnosed on LUS based on the following
findings: absence of lung sliding, absence of B lines, absence of lung pulse
and presence of a lung point. Further, any neonate with clinical suspicion of
pneumothorax in the NICU will undergo a chest x-ray (CXR) for detection.
Therefore, pneumothorax will be noted in two ways, one based on USG findings
(irrespective of symptoms) and the other based on CXR findings (symptomatic).
Pneumothorax will be considered related to intervention if it occurs within 24
hours of life. The need and duration of invasive and non-invasive respiratory
support in NICU and length of hospital stay will be noted for the enrolled
neonates. |