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CTRI Number  CTRI/2025/03/081596 [Registered on: 04/03/2025] Trial Registered Prospectively
Last Modified On: 02/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Role of lung ultrasound in predicting the right time when a newborn on ventilator is ready to breathe on their own 
Scientific Title of Study   Role of lung ultrasound in predicting extubation success in mechanically ventilated neonates 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrChinmay Chetan 
Designation  Associate Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology HIMS SRHU Dehradun UTTARANCHAL 248140 India

Dehradun
UTTARANCHAL
248140
India 
Phone  9871770076  
Fax    
Email  mechinmay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arshpuneet Kaur 
Designation  Senior Resident Neonatology 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology HIMS SRHU,Jolly Grant,Swami Ram Nagar Dehradun UTTARANCHAL 248140 India

Dehradun
UTTARANCHAL
248140
India 
Phone  9872282617  
Fax    
Email  puneeteleven11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arshpuneet Kaur 
Designation  Senior Resident Neonatology 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology HIMS SRHU,Jolly Grant,Swami Ram Nagar Dehradun UTTARANCHAL 248140 India


UTTARANCHAL
248140
India 
Phone  9872282617  
Fax    
Email  puneeteleven11@gmail.com  
 
Source of Monetary or Material Support  
Himalayan Institute of Medical Sciences,SRHU,Jolly Grant,Swami Ram Nagar,Beside Jolly Grant Airport,Dehradun,Uttarakhand 248016,India 
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Department of Neonatology Himalayan Institute of Medical Sciences,SRHU,Jolly Grant,Swami Ram Nagar,Beside Jolly Grant Airport,Dehradun,Uttarakhand 248016,India 
Type of Sponsor  Private medical college 
 
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 Chinmay Chetan  Himalayan Institute of Medical Sciences  NICU-Ward No.110, first floor hospital building, HIMS, Swami Rama Himalayan University, Jolly Grant, Swami Ram Nagar,248016 Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL 		 9871770076

mechinmay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Swami Rama Himalayan University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P285||Respiratory failure of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  All consecutive neonates on conventional ventilation for at least 24 hours 
 
ExclusionCriteria 
Details  Previous extubation failures
Accidental extubation
Life threatening congenital malformations
Upper airway malformations
Surgical cases(Tracheo-esophageal fistula, congenital diaphragmatic hernia, intestinal atresia, necrotising enterocolitis) requiring intubation
Neonates with critical congenital heart disease
Chest deformities  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate predictive ability of lung ultrasound for extubation success.
Word outcome refers to no need of re-intubation within 3 days after extubation(successful extubation)
 		 till 3 days post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1.To develop cut off lung ultrasound score with highest area under curve (AUC)for extubation success.
2.To compare predictive ability of lung ultrasound score on screening 6 versus 12 areas for extubation success.
 		 till 3 days post extubation 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   13/03/2025 
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)  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 - NO
Brief Summary   Both inborn and outborn neonates fulfilling inclusion criteria will ne enrolled. Initially in pre- initiation training, a senior resident will be trained by consultant neonatologist for 1 month. To decrease inter observer variability when k > 0.8, study will be initiated. Subjects will be enrolled 2 hours before extubation. Demographics and perinatal details will be collected. Babies admitted to NICU will be followed prospectively and details of management will be recorded like whether received  surfactant or  not indication of ventilation, mode and  duration of ventilation, settings of ventilator, maximum ventilation index during ventilation,  maximum respiratory severity score (RSS) during ventilation. Lung USG score will be done within 2 hours before extubation. Baby can be extubated if FiO2 requirement < 40 %,   MAP < 8- 10cm H2O,  Respiratory rate of the ventilator < 30/min,   presence of spontaneous breathing,  haemodynamically stable without or with 1 ionotrope, last haemoglobin>10 mg/dl , no metabolic acidosis (pH>7.2)  with PaCO2- < 55mmHg, PaO2>40 mmHg  in arterial blood gas (ABG) done 2 hours before extubation or based on clinical judgement of consultant neonatologist. Post extubation neonate will be shifted to non invasive mode of ventilation (NIV). Lung ultrasound score of those who failed the first extubation attempt and those who were successful will be compared to develop final cut off score for extubation success. 
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