| CTRI Number |
CTRI/2025/03/083472 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study examining the effects of Kinesio-tape and Oro-motor training in preterm babies hospitalized in the neonatal intensive care unit |
|
Scientific Title of Study
|
Effects of Kinesio-tape and Oro-motor training in preterm neonates admitted in NICU- An Observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shrisha Sachin Purohit |
| Designation |
MPT first year |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, PG 1 classroom, second floor, Department of Pediatrics, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9071877077 |
| Fax |
|
| Email |
purohitshrisha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhwani Chanpura |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Staff room, Cabin number 3, Ground floor, Department of Pediatrics, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia.
Vadodara
GUJARAT
391760
India |
| Phone |
9974704464 |
| Fax |
|
| Email |
dhwani.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhwani Chanpura |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University |
| Address |
College of Physiotherapy, Staff room, Cabin number 3, Ground floor, Department of Pediatrics ,Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia.
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9974704464 |
| Fax |
|
| Email |
dhwani.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Neonatal Intensive Care Unit, Department of Pediatrics, Dhiraj General Hospital, Piparia, Vadodara, Gujarat, India, 391760 |
|
|
Primary Sponsor
|
| Name |
Shrisha Sachin Purohit |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be University, Piparia, Waghodia,Vadodara, 391760 GUJARAT India |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Shrisha Sachin Purohit |
Neonatal Intensive Care Unit, Department of Pediatrics,Dhiraj General Hospital |
Sumandeep Vidyapeeth Compound, Waghodia Road, near Pipariya, Vadodara 391760
Vadodara
GUJARAT |
9071877077
purohitshrisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kinesio-tape and Oro-motor stimulation. |
Before starting with the treatment,the neonates skin will be tested for Kinesio-tape sensitivity by applying the tape for 24 hours. We will first sterile the desired area and then apply the kinesio-tape. After the application of the kinesio-tape we will proceed with one session of Oro-motor stimulation for 5 minutes with the Kinesio-tape applied onto the skin of neonates.The treatment will continue until the neonate achieves full independent oral feeding status or till the time of discharge. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
Preterm neonates admitted in NICU with the gestational age between 30weeks (0-7days) to 36weeks (0-7 days)
Preterm neonates who are vitally/ Hemodynamically stable.
Preterm neonate who achieved breast- or bottle-feeding skills (minimum of at least 1ml). |
|
| ExclusionCriteria |
| Details |
Birth weight less than or equal to 1000gm.
Apgar Score less than or equal to 5 at five minutes of birth.
Preterm neonates with presence of congenital abnormalities / metabolic and chromosomal
abnormalities.
Preterm neonates with presence of Neuro-musculoskeletal and cardio- pulmonary disorders.
Having skin allergies (Contraindicated of Kinesio-Taping). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early feeding skills assessment tool (EFS) |
7 days a week or till the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Amount of oral feed intake.
|
7 days a week or till the time of discharge |
| 3. Weight gain(g) will be measured by a digital balance. |
7 days a week or till the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
04/04/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this study the preterm neonates will be included. The pre and post data will be collected using the Early feeding skills assessment tool. The preterm neonates with feeding difficulties due to prematurity will be considered. the treatment will start with Kinesio- tape application followed by one session of Oro-motor stimulation for 5 minutes. |