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CTRI Number  CTRI/2023/05/052288 [Registered on: 03/05/2023] Trial Registered Prospectively
Last Modified On: 19/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A research study to assess the level of knowledge in physiotherapists about premature babies with early problems in the Neonatal Intensive Care Unit.  
Scientific Title of Study   KNOWLEDGE, ATTITUDE AND PRACTICE OF PHYSIOTHERAPISTS WORKING IN NEONATAL INTENSIVE CARE UNIT ON PRETERM NEONATES WITH ACUTE COMPLICATIONS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  T Vaishnavi 
Designation  Post Graduate Student 
Affiliation  NITTE Institute of Physiotherapy 
Address  NITTE Institute of Physiotherapy, NITTE Deemed To be University, Nithyananda Nagar, Deralakatte, Mangaluru. Karnataka 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9482135369  
Fax    
Email  yshnavit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakesh Krishna Kovela 
Designation  Associate Professor  
Affiliation  NITTE Institute of Physiotherapy 
Address  NITTE Institute of Physiotherapy , NITTE Deemed To be University , Nithyananda Nagar, Deralakatte, Mangaluru. KARNATAKA 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7204346274  
Fax    
Email  Rakeshkrishna.pt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  T Vaishnavi 
Designation  Post Graduate Student  
Affiliation  NITTE Institute of Physiotherapy 
Address  NITTE Institute of Physiotherapy, NITTE Deemed To be University, Nithyananda Nagar, Deralakatte, Mangaluru. Karnataka 575018 India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9482135369  
Fax    
Email  yshnavit@gmail.com  
 
Source of Monetary or Material Support  
NITTE Institute of Physiotherapy, NITTE deemed to be university, Nithyananda Nagar, Deralakatte, Dakshina Kannada, Mangaluru, Karnataka, 575018 
 
Primary Sponsor  
Name  NITTE deemed to be university, 
Address  NITTE Institute of Physiotherapy , NITTE deemed to be University , Nithyananda Nagar, Deralakatte, Dakshina Kannada, Mangaluru, Karnataka, 575018 
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 
Rakesh Krishna Kovela  Justice K S Hegde Charitable Hospital  Department no. 20 Physiotherapy Department, Justice K S Hegde Charitable Hospital, Medical Science Complex, University Road, Deralakatte, Mangaluru, Karnataka, India, 575018
Dakshina Kannada
KARNATAKA 
7204346274

Rakeshkrishna.pt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  preterm neonates with acute complications 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Physiotherapists who are working in NICU.
Physiotherapists who have working experience of more than 2 years in a NICU setup.
 
 
ExclusionCriteria 
Details  Physiotherapists who are not willing to participate in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self made Questionnaire  30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
No Secondary Outcomes  NIL 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
Final Enrollment numbers achieved (Total)= "168"
Final Enrollment numbers achieved (India)="168" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/08/2023 
Date of Study Completion (India) 24/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

As of 2019, every year globally, an estimated 15 million babies are born too soon, which is greater than one in ten infants, and the complications arising due to prematurity claim the lives of almost 1 million children. 2.7% of the 13 million live births out of the 15 million preterm births each year worldwide have moderate or severe neurological involvement and 4.4% have mild neurological involvement as stated by WHO. In India 3,341,000 premature births occur each year, and 361,600 under-five deaths are directly due to preterm complications. 

Essential new-born care as well as basic care for feeding support, infections, and breathing difficulties can mean the difference between life and death for preterm babies and by enhancing treatment for premature children, we can better handle the challenges brought on by their immaturity and their eventual evolutionary prognosis. For a better prognosis for high-risk neonates, diagnostic and therapeutic methods are used in the NICU.

 These techniques include percussion, vibration, aspiration, stimulating cough, postural drainage, positioning (as a part of chest physiotherapy), massage therapy, gentle joint compressions, tactile kinaesthetic stimulation, passive range of motion exercises (as a part of neuromuscular physiotherapy) Oro-motor stimulation techniques (stroking or applying pressure to the cheeks, lips, jaw, tongue, palate, and gums, as well as non-nutritive suction from a pacifier, in the peri- and intra-oral regions) and promote Kangaroo Mother care.

The Neonatal Intensive Care Unit (NICU) is a specialized unit created for new-borns who are ill, unstable, and who need medical care.Holistic care must incorporate a multidisciplinary team approach (which includes paediatricians, nurses, and physiotherapists). To improve the prognosis of premature babies in NICU, Physiotherapy plays a major role. Paediatric physiotherapy has advanced to include neonatal physiotherapy. Because of this, physiotherapists who work in neonatal care settings like the NICU and intermediate care facilities need to have advanced clinical skills. The physiotherapist carries out a customized program from cardiopulmonary and neuromuscular physiotherapy approaches which is suitable for the gestational age of the premature baby, and acute complications faced by preterm infants, supporting neurobehavioral and neurodevelopmental, according to the needs of the baby, while involving the parents in the process with family education.

The purpose of this study is to determine whether the physiotherapists who are involved in NICU, are aware of the necessary therapy and guidelines for the treatment of acute complications of preterm infants and whether these guidelines are being followed and performed routinely in the NICU setup. 

 
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