| CTRI Number |
CTRI/2025/03/081596 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| 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
|
|
|
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
|
|
|
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)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2025 |
| Date of Study Completion (India) |
15/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Both inborn and outborn neonates fulfilling inclusion criteria were enrolled. Initially in pre- initiation training, a senior resident was trained by consultant neonatologist for 1 month. To decrease inter observer variability when k > 0.8, study was initiated. Subjects were enrolled 2 hours before extubation. Demographics and perinatal details were collected. Babies admitted to NICU were followed prospectively and details of management were 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 were 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. Lung ultrasound score of those who failed the first extubation attempt and those who were successful were compared to develop final cut off score for extubation success using both 6 ara and 12 area approach. In 6 area and 12 area approach, cut off score of 6 and 14 yielded maximum predictive value. Both scoring systems showed statistically comparable and moderately good performance in predicting extubation success with slightly better sensitivity in 12 area score and better specificity in 6 area score. |