FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mayank.neonat@aiimsrishikesh.edu.in].

  6. 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.

  7. 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.

 
Close