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CTRI Number  CTRI/2024/03/064911 [Registered on: 28/03/2024] Trial Registered Prospectively
Last Modified On: 25/02/2026
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   Physiotherapy rehabilitation management in neonatal respiratory distress syndrome 
Scientific Title of Study   Effect of Physical Rehabilitation using Oro Motor Stimulation, Manual Airway Clearance Technique, Positioning, Tactile and Kinesthetic Stimulation (PROMPT) protocol on Respiratory and Neuromuscular Function in Neonatal Respiratory Distress Syndrome (NRDS)- A 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  Dr Sharath Hullumani V  
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)  
Address  Room No. 142 , Ground Floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Swangi Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9964066927  
Fax    
Email  sharathhullumani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Irshad Qureshi 
Designation  Professor, Principal 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)  
Address  Room No. 12 , Ground Floor, Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Swangi Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9406010010  
Fax    
Email  irshadphysio@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sharath Hullumani V  
Designation  Assistant Professor 
Affiliation  Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU)  
Address  Room No. 142 , Ground Floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Swangi Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9964066927  
Fax    
Email  sharathhullumani@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe, Wardha, Maharasthra, India  
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research (DU)  
Address  Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha 
Type of Sponsor  Research institution and hospital 
 
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 Sharath Hullumani V  Acharya Vinoba Bhave Rural Hospital   Room No.19, 2nd Floor, Neonatal Intensive Care Unit(NICU), Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU),Sawangi Meghe
Wardha
MAHARASHTRA 		 9964066927

sharathhullumani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Deemed to be University Institutional Ethics Committe   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  Conventional treatment  4 weeks for 30 minutes 
Intervention  PROMPT Protocol  Oromotor stimulation, Manual Airway Clearance technique, Positioning, Tactile and Kinesthics stimulation for 4weeks continuously fro 30 minutes  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  b) Vital Signs: Inclusion criteria involve neonates with a pulse rate (PR) surpassing 160 beats per minute, a respiratory rate (RR) exceeding 60 breaths per minute or exhibiting apnea, and a diastolic blood pressure (DBP) below 60 mm Hg.
c) Chest Examination: Eligibility encompasses neonates displaying reduced bilateral or unilateral airway entry, abnormal sounds such as grunting, indications of intercostal retractions, substernal retractions, suprasternal retractions, and nasal flaring. Additionally, X-ray findings indicating white lungs, fine reticular granularity of the parenchyma, and airway bronchograms are considered.
d) Skin Examination: Neonates with pale or bluish-colored skin are candidates for inclusion.
e) ABG Analysis: Inclusion criteria cover neonates with arterial blood pH below 7.20, arterial blood PCO2 of 60 mm Hg or higher, arterial blood PO2 of 50 mm Hg or less, and an oxygen saturation ranging from 70% to 100%. 
 
ExclusionCriteria 
Details  a) Significant Congenital Abnormalities
b) Profound Hemodynamic Instability
c) Life-Threatening Situations: Neonates with urgent and critical medical conditions other than NRDS, necessitating immediate interventions, may be ineligible.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Ballard Score
Oral Motor Assessment Scale 		 Baseline, 1st week, 2nd week,3rd week and 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
APGAR Score
Neonatal Network scale 		 Baseline, 1st week, 2nd week,3rd week and 4th week 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/04/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 21-03-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

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

The aim of this study is to explore the influence of incorporating the PROMPT protocol adjunct to medical treatment on pulmonary, respiratory and neuromuscular function in preterm infants diagnosed with Neonatal Respiratory Distress Syndrome (NRDS).

 
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