| CTRI Number |
CTRI/2026/01/101977 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Combined effects of Thoracic squeeze technique and Body positioning in acute respiratory distress syndrome in infants |
|
Scientific Title of Study
|
Combined effects of Thoracic squeeze technique and therapeutic body positioning in acute respiratory distress syndrome in infants: a pilot randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chavan Mrunali Maruti |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of physiotherapy, srinivas University |
| Address |
Department of neuro physiotherapy,institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district ,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7020083995 |
| Fax |
|
| Email |
mrunali241099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika Gopal S |
| Designation |
Associate professor |
| Affiliation |
Institute of physiotherapy, srinivas University |
| Address |
Department of neurophysiotherapy,Institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district ,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9995507379 |
| Fax |
|
| Email |
radhikaradhu1590.cp@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chavan Mrunali Maruti |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of physiotherapy, srinivas University |
| Address |
Institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district ,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7020083995 |
| Fax |
|
| Email |
mrunali241099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chavan Mrunali Maruti |
| Address |
Department of neurophysiotherapy,institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district ,575001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Chavan Mrunali Maruti |
NICU of Srinivas institute medical science and research centre Mukka |
Srinivas hospital, Srinivas integrated campus, Srinivas nagar, Mukka, Surathkal, Mangaluru - 575021, Karnataka, India.
Dakshina Kannada
KARNATAKA |
7020083995
mrunalichavan241099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE (IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Conventional physiotherapy treatment will be given to infants with ARDS for 3 session per day for 2 weeks |
| Intervention |
Thoracic squeeze technique and therapeutic body positioning |
Thoracic squeeze technique and therapeutic body positioning will be given to infants with ARDS will given for 3 sessions per day for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1.Known case of ARDS
2.Clinically and haemodynamically stable as determined by the attending neonatologist
3.Age– Preterm infants (less than 37 week of gestational age) upto 1 years
4. Both genders- female and male
5. Infants weight more than 1kg
6. Granting of parental consent. |
|
| ExclusionCriteria |
| Details |
Infants, diagnosed with -
1.persistent pulmonary hypertension
2.meconium aspiration syndrome,
3.congenital heart defects,
4.post cardiothoracic surgery
5.pleural effusion, and pneumothorax
6. Genetic syndromes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Silverman Anderson Respiratory Severity Score |
Baseline ,after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Respiratory Rate (breaths/min) |
Baseline, after 2 weeks |
| Oxygen Saturation |
Baseline, after 2 weeks |
| Arterial blood gas |
Baseline, after 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2026 |
| Date of Study Completion (India) |
06/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/06/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Purpose : The primary purpose of this protocol is to evaluate the combined effects of thoracic squeeze technique (TST) and therapeutic body positioning (TBP) in acute respiratory distress syndrome in infants. By comparing the combined effects of TST and TBP with conventional physiotherapy by treating ARDS in infants.
|