CTRI

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CTRI Number

CTRI/2025/07/090068 [Registered on: 02/07/2025] Trial Registered Prospectively

Last Modified On:

01/07/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Correlation of Clinical and ultrasound lung findings in newborns born after 34 weeks of gestation age with respiratory distress : a study from Eastern India.

Scientific Title of Study

Correlation of Clinical and USG lung in newborns born after 34 weeks of gestation age with respiratory distress : a prospective observational study at a Tertiary Care Center in Eastern India.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr. Archisman Mondal
Designation	DNB trainee
Affiliation	Neotia Bhagirathi Woman and Child Care Centre
Address	Neotia Bhagirathi Woman and Child Care Centre New Town Premises No 27 0327 Plot No: DG-20 17 DG 20 21 Street No 327, Action Area ID New Town Kolkata North Twentyfour Parganas WEST BENGAL 700156 India
Phone	8961653717
Fax
Email	archismanmondal1995@gmail.com

Details of Contact Person
Scientific Query

Name	Dr. Bikramjit Das
Designation	Consultant Neonatologist and Pediatrician
Affiliation	Neotia Bhagirathi Woman and Child Care Centre
Address	Neotia Bhagirathi Woman and Child Care Centre New Town Premises No 27 0327 Plot No: DG-20 17 DG 20 21 Street No 327, Action Area ID New Town Kolkata North Twentyfour Parganas WEST BENGAL 700156 India
Phone	9216249740
Fax
Email	bikramjit.wishes@gmail.com

Details of Contact Person
Public Query

Name	Dr. Bikramjit Das
Designation	Consultant Neonatologist and Pediatrician
Affiliation	Neotia Bhagirathi Woman and Child Care Centre
Address	Neotia Bhagirathi Woman and Child Care Centre New Town Premises No 27 0327 Plot No: DG-20 17 DG 20 21 Street No 327, Action Area ID New Town Kolkata WEST BENGAL 700156 India
Phone	9216249740
Fax
Email	bikramjit.wishes@gmail.com

Source of Monetary or Material Support

Neotia Bhagirathi Woman and Child Care Centre New Town Premises No 27 0327 Plot No: DG-20 17 DG 20 21 Street No 327, Action Area ID New Town Kolkata-700156

Primary Sponsor

Name	Neotia Bhagirathi Woman and Child Care Centre
Address	Neotia Bhagirathi Woman and Child Care Centre New Town Premises No 27 0327 Plot No: DG-20 17 DG 20 21 Street No 327, Action Area ID New Town Kolkata
Type of Sponsor	Private hospital/clinic

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 Bikramjit Das	Neotia Bhagirathi Woman and Child Care Centre	Neotia Bhagirathi Woman and Child Care Centre New Town Premises No 27 0327 Plot No: DG-20 17 DG 20 21 Street No 327, Action Area ID New Town Kolkata North Twentyfour Parganas WEST BENGAL	9216249740 bikramjit.wishes@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IHREC_BNWCCC	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: P221\|\|Transient tachypnea of newborn,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	1.00 Day(s)
Age To	30.00 Day(s)
Gender	Both
Details	1.Completed 34 wks weeks of gestational age. 2.Onset of respiratory distress within 6 hrs of birth.

ExclusionCriteria

Details

1.Congenital Heart Disease(Either Diagnosed Antenatally or postnatally)
2.Congenital malformation incompatible with life.
3.Pneumothorax and other forms of air leaks like pneumomediastinum.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
1. Respiratory Distress Scoring(DOWNE score) 2. USG scoring to assess the prognosis of disease pathology. 3. Correlation between USG score and Downe score 4. Correlation between USG and Chest X-Ray finding 5. Correlation between Chest X-ray and Downe scoring 6. Chest X-Ray finding.	Baseline and 24 hours later

Secondary Outcome

Outcome	TimePoints
1. Duration of Oxygen requirement.(In hours) 2. Duration of Ventilation.(In hours) 3. Cardiovascular Instability 4. Renal Dysfunction 5. Neurological Disability 6. Sepsis	Baseline & 24 hours later

Target Sample Size

Total Sample Size="150"
Sample Size from India="150"
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)

15/07/2025

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="0"
Months="9"
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 - NO

Brief Summary

Our project Titled “Correlation of Clinical and USG lung in newborns born after 34 weeks of gestation age with respiratory distress : a prospective observational study at a Tertiary Care Center in Eastern India.” which is a unicentric study , at Bhagirathi Neotia Woman and Child Care Centre, Newtown, Kolkata. This study aims to look at the correlation between ultrasound lung findings and clinical features. If a good correlation is found then USG can replace chest X-ray as a modality of diagnosis in newborns with respiratory distress. Chest X-ray we know involves radiation exposure.

The total number of cases that are proposed to be enrolled is 150 over a period of 12 months which will be feasible at the Bhagirathi Neotia Woman and Child Care Centre, Newtown, Kolkata in the above period.