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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
preterm neonates with acute complications |
|
Intervention / Comparator Agent
|
|
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. |