| CTRI Number |
CTRI/2024/07/071626 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Evaluating the immediate effect of oromotor stimulation tecniques given intraorally,extraorally or combined in preterm babies |
|
Scientific Title of Study
|
Immediate Effect Of Intraoral Versus Extraoral Versus
Combined Oromotor Stimulation
In Preterm Neonates A
Randomized Control 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 |
SHRUTI NAGESH PRABHU |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No 13, Pediatric Physiotherapy, SDM College Of Medical Sciences And Hospital Sattur,
Dharwad
OPD No 13, Pediatric Physiotherapy, SDM College Of Medical Sciences And Hospital Sattur,
Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9972587964 |
| Fax |
|
| Email |
shruti9720prabhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JYOTI JEEVANNAVAR |
| Designation |
PROFESSOR |
| Affiliation |
SDM College of Physiotherapy |
| Address |
OPD No 13, Pediatrics Physiotherapy, Shri Dharmasthala
Manjunatheshwara Hospital And Medical Sciences, Sattur, Dharwad
580009
Dharwad
KARNATAKA
580009
India
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
|
| Email |
jyoti.jeevannavar@sdmuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
JYOTI S. JEEVANNAVAR |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF PHYSIOTHERAPY |
| Address |
OPD No 13, Pediatrics Physiotherapy, Shri Dharmasthala
Manjunatheshwara Hospital And Medical Sciences, Sattur, Dharwad
580009
Dharwad
KARNATAKA
580009
India
Dharwad
KARNATAKA
580009
India |
| Phone |
9972189767 |
| Fax |
|
| Email |
jyoti.jeevannavar@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Medical Sciences And Hospital, Sattur, Dharwad 580009
INDIA |
|
|
Primary Sponsor
|
| Name |
SHRUTI NAGESH PRABHU |
| Address |
Shri Dharmasthala Manjunatheshwara College Of Physiotherapy
Manjushree Nagar Sattur Dharwad 580009 India |
| Type of Sponsor |
Other [self] |
|
|
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 JYOTI JEEVANNAVAR |
SDM COLLEGE OF MEDICAL SCIENCES |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL
PAEDIATRIC PHYSIOTHERAPY DEPARTMENT
PAEDIATRIC OPD 13
SATTUR, DHARWAD- KARNATAKA
580009
Dharwad
KARNATAKA |
9972189767
jyoti.jeevannavar@sdmuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OROMOTOR ISSUES IN PRETERM INFANTS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
ORO MOTOR STIMULATION |
INTRAORAL STIMULATION
EXTRAORAL STIMULATION
COMBINED STIMULATION |
| Intervention |
oromotor intervention |
INTRAORAL OMS 6 mins
Upper gum for 1 min with minimum 5
repetitions
1. Place finger at the centre of the
gum. With firm sustained pressure
slowly move the finger over the
gum towards the cheek and back of
the jaw.
2. Return to the centre of the mouth.
3. Repeat for opposite side.
Lower gum for 1 min with minimum 5
repetitions)-
1. Place finger at the centre of the
gum. With firm sustained pressure
slowly move toward the back of the
mouth.
2. Return to the centre of the mouth.
3. Repeat for opposite side
Internal cheek for 1 min with minimum
5 repetitions
1. Place finger at the centre of the
cheek. With slight stretch over the
cheek perform circular motions
clockwise and anticlockwise.
Lateral border of the tongue 2 times
each side for 1 min
1. Place finger at lateral border of the
tongue between the side blade of
the tongue and the lower gum.
2. Move the finger toward midline,
pushing the tongue towards the
opposite direction.
Midblade of the tongue 1 min
1. Place index at the centre of the
mouth over the centre blade of the
tongue.
2. Give firm sustained gentle
downward pressure into to the
tongue.
Elicit a suck 1 min-place finger at the
midline,centre of the palate ,gently
stroke the palate to elicit a suck.
EXTRAORAL OMS 5 mins
Cheeks-gently tap the cheeks with the
index finger 8 times each cheek or 1
min
1. Place index finger at the base of the
nose.
2. Compress the tissue, move finger
toward the ear, then down and
toward the corner of the lip i.e. C
pattern.
3. Repeat for other side. for 1 min
with minimum 5 repetitions
Upper lip-for 1 min with minimum 5
repetitions
1. Place index finger at the corner of
the upper lip.
2. Compress the tissue.
3. Move the finger away in a circular
motion, from the corner toward the
centre and to the other corner.
Lower lip-for 1 min with minimum 5
repetitions
1. Place index finger at the corner of
lower lip.
2. Compress the tissue.
3. Move the finger away in a circular
motion from the corner toward the
centre and to the other corner
Philtrum and mentolabial sulcus -1
min i.e.30 seconds each lip
Intermittent pressure with the fingertip
from the corners of the mouth to the
centre of the philtrum and mentolabial
sulcus.
5seconds hold for 5 repetition or 1
min
Sustained gentle intermittent pressure
over the philtrum and the mentolabial
sulcus while causing approximation of
the lips.
COMBINED OMS 11mins
This will include the combination of
both intraoral and extraoral
stimulation.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1. Neonates of 28 - 37 weeks of
gestation.
2. Clinically stable neonates.
3. Neonates of either gender |
|
| ExclusionCriteria |
| Details |
1. Neonates with congenital
anomalies affecting feeding like
cleft lip, cleft palate.
2. Neonates on mechanical
ventilation.
3. Neonates with facial nerve palsy
4. Congenital cardiac conditions
ASD VSD |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preterm Oral Feeding Readiness Assessment Scale [POFRAS] |
the scale will be administered at first reference and later immediately after the intended intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/08/2024 |
| 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
|
This study is focused on comparing the outcomes of three different
approaches to oromotor stimulation (OMS) in preterm infants: internal
OMS, which involves manipulative actions within the mouth; external OMS,
which involves manipulative actions outside the mouth; and combined OMS,
which utilizes a combination of both techniques. The objective is to
determine whether any of these approaches are equally effective in
enhancing sucking and feeding abilities in preterm infants. If it is found that
each protocol yields comparable results, it would lead to a significant
reduction in the time required for treatment while still providing substantial
benefits for the child’s feeding development. This would mean that
clinicians could choose the most efficient OMS approach without
compromising the quality of care, ultimately resulting in better outcomes
for preterm infants. |