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CTRI Number  CTRI/2025/07/092056 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Process of Care Changes 
Study Design  Randomized Factorial Trial 
Public Title of Study   A study to compare using lung ultrasound to give surfactant while visualizing the airway with realtime video versus giving surfactant based on the percentage of oxygen required (current practice) in premature newborns with breathing difficulty at birth. 
Scientific Title of Study   LUNG ULTRASOUND-GUIDED SURFACTANT THERAPY AND VIDEO LARYNGOSCOPY FOR THIN CATHETER INTUBATION IN PRETERM NEONATES OF LESS THAN 32 WEEKS GESTATION WITH RESPIRATORY DISTRESS AT BIRTH: A 2x2 FACTORIAL DESIGN CLINICAL TRIAL 
Trial Acronym  LUNAVIS - Lung Ultrasound with Neonatal Airway guidance using Video laryngoscope Intubation for Surfactant 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prithiviraj Kesavan 
Designation  Senior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9629574685  
Fax    
Email  raj.prithivi04@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Venkataseshan Sundaram 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9478001129  
Fax    
Email  venkatpgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Venkataseshan Sundaram 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Division of Neonatology, Department of Pediatrics, Advanced Pediatric Centre, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9478001129  
Fax    
Email  venkatpgi@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Chandigarh 160012. 
 
Primary Sponsor  
Name  Prithiviraj Kesavan 
Address  Division of Neonatology, Department of Pediatrics, Level 3, F block, Nehru Hospital, Advanced Pediatric Centre, PGIMER, Sector 12, Chandigarh, 160012  
Type of Sponsor  Other [Primary Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkataseshan Sundaram  Postgraduate Institute of Medical Education and Research  Division of Neonatology, Department of Pediatrics, Level 3, F block, Nehru Hospital, Advanced Pediatric Centre, PGIMER, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9478001129

venkatpgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Direct laryngoscopy assisted LISA group  In Intensive care nursery and NICU, Direct Laryngoscopy (using HEINE Classic and Miller Fiber Optic Blades with Easyclean LED SLIM Laryngoscope handles, HEINE Optotechnik GmbH & Co. KG, Gilching, Deutschland) with blade sizes Miller 00 (for weight less than 750 grams), Miller 0 (for weight 750 to 1500 grams), Miller 1 (for weight more than 1500grams) will be the standard type of laryngoscope for all neonates included in this trial. Cords will be visualized using DL followed by placing the thin catheter (Surfcath, by Vygon, Ecouen, Paris) between the vocal cords at a depth described by the manufacturer of thin catheter. After successful catheter placement, laryngoscope will be withdrawn. HCP will be at liberty to use a different blade size if the suggested size is not offering desired view. Introduction of the blade followed by removal will be defined as an ‘attempt’ except the blade is removed to replace that with a different size blade. Failed attempt is defined as inability to complete the surfactant administration due to displacement of the catheter or failure to place the thin catheter below the vocal cords. Maximum three attempts will be allowed for an HCP following which a senior HCP will attempt with the same type of laryngoscope. In case of failure after three attempts by senior HCP, the treating clinician is at discretion of abandoning the procedure or repeat the attempt with other type of laryngoscope. Successful completion of the procedure is defined as removing the thin catheter after instilling the complete dose of surfactant as prescribed. Analgesia or sedation is not currently practiced routinely during LISA. However, in exceptional cases, analgesia or sedation will be at the discretion of the HCP who is undertaking the procedure. If given, a note will be made in the CRF.  
Intervention  Lung Ultrasound guided surfactant administration group  Soon after randomization but not later than 2 hours from birth, a LUS will be performed by a trained neonatologist who is not involved in the clinical trial while the neonate is initiated on CPAP with an appropriate concentration of FiO2. The CPAP pressure required (in cm H2O) to mitigate or minimize the respiratory distress and the FiO2 required to target the pre-ductal SpO2 shall be documented. LUS will be done as per a pre-tested standard operating protocol (SOP) for performing LUS in neonates for the purpose of scoring to diagnose respiratory distress syndrome (RDS)(20).A high frequency linear or micro-linear (hockey-stick shaped) probe will be used for the LUS examinations. Longitudinal orientation of the linear probe will be preferred where the probe orientation marker is aligned to the 12- clock position (North pointing). LUS score will be calculated by performing longitudinal scans of both the hemi thoraces in three regions per hemithorax – namely upper anterior, lower anterior and lateral (Brat et al). Each scan area will be assigned a score ranging from 0 to 3 making a total possible score of 18 (for six regions). In case a same region shows two different patterns, the pattern which is more severe will be taken for the final score. 
Comparator Agent  Pressure and FiO2 based criteria  The preterm neonate will be continued on CPAP and an appropriate FiO2 for the target SpO2. In this group, surfactant by LISA will be administered at a CPAP of 6 cmH2O and an FiO2 of 30%. In Intensive care nursery and NICU, nCPAP will be the standard method of non-invasive respiratory support for all neonates included in this trial. Clinical criterion for deciding surfactant therapy will be defined as FiO2 Requirement more than 0.30 to maintain a SpO2 90% for at least 15 mins unless rapidly deteriorating after ruling out any obstructive or mechanical causes of CPAP failure. Surfactant decision can also be taken by the in-charge clinician if the enrolled patient has respiratory acidosis defined as PaCO2 greater than 60 mm Hg and pH less than 7.2 in an arterialized capillary or arterial blood gas sample or apnea requiring bag and mask or Tpiece mask ventilation 
Intervention  Video laryngoscopy assisted LISA group  Participants randomized to VL assisted LISA group will undergo LISA with the assistance of a hand held Neonatal Video Laryngoscope (Hugemed VL3RorVL4R series, Shenzhen, China) with blade sizes Miller 00 (for weight less than 750 grams), Miller 0 (for weight 750 to 1500 grams), Miller 1 (for weight greater than 1500grams). Cords will be visualized using VL followed by placing the thin catheter (Surfcath, by Vygon, Ecouen, Paris) between the vocal cords at a depth described by the manufacturer of thin catheter. After successful catheter placement, laryngoscope will be withdrawn. HCP will be at liberty to use a different blade size if the suggested size is not offering desired view. Introduction of the blade followed by removal will be defined as an ‘attempt’ except the blade is removed to replace that with a different size blade. Failed attempt is defined as inability to complete the surfactant administration due to displacement of the catheter or failure to place the thin catheter below the vocal cords. Maximum three attempts will be allowed for an HCP following which a senior HCP will attempt with the same type of laryngoscope. In case of failure after three attempts by senior HCP, the treating clinician is at discretion of abandoning the procedure or repeat the attempt with other type of laryngoscope. Successful completion of the procedure is defined as removing the thin catheter after instilling the complete dose of surfactant as prescribed. Analgesia or sedation is not currently practiced routinely during LISA. However, in exceptional cases, analgesia or sedation will be at the discretion of the HCP who is undertaking the procedure. If given, a note will be made in the CRF. 
 
Inclusion Criteria  
Age From  0.10 Day(s)
Age To  0.40 Day(s)
Gender  Both 
Details  Preterm neonates with more than 25 and less than32 weeks of gestational age.
Respiratory distress since birth or onset within 2 hours from birth. Require continuous positive airway pressure support of at least 5 cm H2O and FiO2 of more than 0.21 to maintain preductal pulse saturation in 91 to 95% target range.
 
 
ExclusionCriteria 
Details  Major or life-threatening congenital anomalies.
Hemodynamic instability requiring vasopressors or inotropes or inhaled nitric oxide.
Requiring endotracheal intubation during resuscitation at birth or due to insufficient spontaneous respiratory efforts to initiate CPAP.
Pulmonary air leaks (pneumothorax, pneumomediastinum) before the administration of first dose of surfactant.
Refusal of consent by the 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 
1. Composite outcome of BPD (as per Jensen et al criteria) or death(all cause, before discharge) at term equivalent age(40 weeks Post-Menstrual age)
2. Proportion of neonates with successful completion of the surfactant administration procedure in the first attempt
 		 1. 40 weeks post menstrual age.
2. 72 hours of age. 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of neonates who received surfactant early( less than 2 hrs of birth) & late( more than 2 hrs of birth)  72 hours of life 
Proportion of neonates needing Invasive mechanical ventilation within first 3 days of life  72 hours of life 
Max FiO2 level required to maintain preductal SpO2 between 91 to 95% before the administration of first dose of surfactant  72 hours of life 
Need for second/repeat dose of surfactant  72 hours of life 
Number of attempts for intratracheal catheter passage  72 hours of life 
Need for multiple attempts for successful surfactant administration  72 hours of life 
Episodes of bradycardia during surfactant administration procedure  72 hours of life 
Episodes of desaturation less than 80 percent during surfactant administration procedure  72 hours of life 
Duration of non-invasive & invasive respiratory support before 40 weeks post menstrual age.   40 weeks Post menstrual age 
Incidence of intubation during the surfactant administration procedure  72 hours of life 
Proportion of neonates who had Pneumothorax post surfactant administration  72 hours of life 
Maximum FiO2 requirement during the hospital stay  40 weeks Post menstrual age 
Duration of hospital stay  40 weeks Post menstrual age 
Incidence of BPD & its severity   40 weeks Post menstrual age 
Incidence of ROP  40 weeks Post menstrual age 
Incidence of IVH  40 weeks Post menstrual age 
Mortality rate  40 weeks Post menstrual age 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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)   15/08/2025 
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="3"
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
  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
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [venkatpgi@gmail.com].

  6. For how long will this data be available start date provided 15-08-2025 and end date provided 14-08-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study intends to compare lung ultrasound guided surfactant administration with standard criteria guided surfactant administration for a 10 percent absolute reduction in the incidence of a composite outcome of death or BPD by 40 weeks PMA in preterm neonates of  less than 32 weeks’ gestation with respiratory distress at or within 2 hours from birth and to compare video laryngoscopy (VL) assisted versus fibre optic direct laryngoscope (FODiL) assisted less invasive surfactant administration for improvement in procedural success rate by at least 10 percent in the same population of preterm neonates.

 
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