| CTRI Number |
CTRI/2025/12/099420 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| 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
|
Gentle touch and mouth exercises to help preterm infants feed
better,grow healthier and breathe better
|
|
Scientific Title of Study
|
Impact of a combined Oromotor and Tactile
Intervention program for Improving Weight Gain, Feeding Tolerance, and Respiratory
Function in Preterm Neonates with Respiratory Distress in the Special New born Care
Unit: A Randomized Controlled 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 |
Yosuva k |
| Designation |
Post graduate student in Pediatric physiotherapy |
| Affiliation |
Mother theresa Post graduate and Research Institute of Health sciences |
| Address |
Department of pediatric physiotherapy, College of physiotherapy,Mother theresa Post graduate Institude of Health Sciences,Indira nagar,Puducherry ,India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9789316430 |
| Fax |
0413-2277594 |
| Email |
kyosuva14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rathish S |
| Designation |
Associate professor |
| Affiliation |
Mother theresa Post graduate and Research Institute of Health sciences |
| Address |
Department of pediatric physiotherapy, College of physiotherapy,Mother theresa Post graduate Institude of Health Sciences,Indira nagar,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9944319384 |
| Fax |
0413-2277594 |
| Email |
rathish@mtpgrihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rathish S |
| Designation |
Associate professor |
| Affiliation |
Mother theresa Post graduate and Research Institute of Health sciences |
| Address |
Department of pediatric physiotherapy, College of physiotherapy,Mother theresa Post graduate Institude of Health Sciences,Indira nagar,Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9944319384 |
| Fax |
0413-2277594 |
| Email |
rathish@mtpgrihs.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Government Women and Children Hospital Lakshmi nagar, Annamalai Nagar, Puducherry, 605006 PONDICHERRY ,India |
|
|
Primary Sponsor
|
| Name |
Yosuva K |
| Address |
Department of pediatric physiotherapy, College of physiotherapy,Mother Theresa
Post graduate Institude of Health Sciences,Indira
nagar,Puducherry
pondicherry, 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 Jhonson Reddy |
Rajiv Gandhi Government Women And Childrens Hospital |
Special New Born Care Unit (SNCU) Room No 323 (NICU) II floor
Pondicherry
PONDICHERRY |
94431 12468
413 2205020
azygos414@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mother theresa Post graduate and Research Institute of Health sciences ,Institute Ethical Commitee ( human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combination of Oromotor and tactile intervention |
This group will receive the following interventions twice daily, before scheduled feedings, for the duration of their hospital stay up to a maximum of 4 weeks. Mothers will be trained to continue the tactile stimulation at home if the neonate is discharged before the 4week in-hospital period is complete and followed up through video calls. . Oromotor Stimulation (Administered for 10 minutes per session): include peri-oral,inta-oral and non-nutritive sucking.). Tactile Stimulation (Administered for 25 minutes per session):
Tactile stimulation will be administered in two phases with firm but gentle strokes of approximately 5-10 seconds duration per stroke, using the palms of the hands.
Phase I: Prone Lying:
(a) Head: Twelve alternating strokes from the forehead hairline, over the scalp, down to the nape of the neck.
(b) Neck: Twelve simultaneous outward strokes from the midline of the neck.
(c) Shoulders: Twelve simultaneous outward strokes from the midline of the shoulders.
(d) Back: Twelve alternating long, firm strokes from the nape of the neck down to the buttocks.
Phase II: Supine Lying:
(a) Forehead: Twelve simultaneous outward strokes from the midline of the forehead.
(b) Cheeks: Twelve simultaneous rotating and clockwise strokes from the side of the nose.
(c) Chest: Twelve "butterfly" strokes originating from the midline, moving upwards, outwards, downwards, and inwards back to the starting point.
(d) Abdomen: Gentle clockwise strokes around the abdomen, starting from the appendix area, avoiding the epigastrium and any medical probes, for a total of twelve strokes.
(e) Upper Limbs (each separately): Twelve alternating strokes from the shoulders to the wrist.
(f) Lower Limbs (each separately): Twelve alternating strokes from the hips to the ankles.
(g) Palms: Twelve alternating strokes from the wrist to the fingertips.
(h) Soles: Twelve alternating strokes from the heel to the toe tips.
The combined oromotor and tactile stimulation will be administered for approximately 40-45 minutes (10 minutes oromotor + 25 minutes tactile along with conventional physiotherapy) twice daily, before feeding, for up to 2 weeks during the neonates hospital stay. Mothers of neonates discharged before 2 weeks will be instructed, followed up through mobile phones and encouraged to continue the tactile stimulation (as taught) twice daily at home for a total duration of 4 weeks from the start of the intervention. Oromotor stimulation at home will be discussed based on the neonates feeding progress and maternal comfort level. |
| Comparator Agent |
conventional physiotherapy |
This group will receive standard physiotherapy care (tactile stimulation and passive movement. Tactile stimulation as described in Phase I and Phase II above, following the same duration and frequency (25-30 minutes) and passive movements (10min) twice daily before feeding, for up to 2 weeks in the hospital, with maternal continuation of tactile stimulation at home for a total of 4 weeks if discharged early). Tactile stimulation (25-30 minutes) and passive movements (5-10 minutes) will be administered twice daily, before feeding, for up to 2 weeks during the neonates hospital stay.
Mothers of neonates discharged before 2 weeks will be instructed and encouraged to continue the tactile stimulation (as taught) twice daily at home for a total duration of 4 weeks from the start of the intervention. Passive movements at home will be at the discretion of the parents.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Admitted to the Special Newborn Care Unit (SNCU) with respiratory distress
Demonstrating clinical signs of dysfunctional sucking, swallowing, and breathing coordination during feeding attempts, irrespective of their gestational age at birth.
Have parents or legal guardians who provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Neonates will be excluded from the study if they present with any significant comorbidities or clinical instability that, in the judgment of the attending neonatologist and the principal investigator, would interfere with their participation in the study procedures, confound the study outcomes, or pose an increased risk |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| weight gain |
Weight gain will be measured daily at a fixed time using calibrated
electronic scales, following a standardized protocol.Assessment by trained assessors at predefined time points baseline, 2
weeks and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Infant Breastfeeding Assessment Tool |
1st week (baseline)
4th week &
8th week |
| Downes score |
1st week (baseline)
4th week &
8th week |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
20/01/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
Background: Preterm birth is a major global health concern, often complicated by respiratory distress and feeding difficulties due to immature coordination of sucking, swallowing, and breathing. These challenges contribute to poor weight gain, feeding intolerance, and prolonged hospitalization. Oromotor and tactile stimulation have individually shown benefits, but evidence on their combined effects in preterm neonates with respiratory distress remains limited. Aim: To evaluate the impact of a combined oromotor and tactile stimulation program on weight gain, feeding tolerance, and respiratory function in preterm neonates with respiratory distress admitted to a Special Newborn Care Unit (SNCU). Methods: A randomized controlled trial was conducted on 40 preterm neonates (20 intervention, 20 control) admitted to the SNCU, Rajiv Gandhi Government Women and Child Hospital, Puducherry. The intervention group received combined oromotor and tactile stimulation twice daily for up to four weeks in addition to standard care, while the control group received standard physiotherapy and nursing care. Outcomes were assessed using daily weight measurements, Infant Breastfeeding Assessment Tool (IBFAT) scores, and Downes scores for respiratory distress at baseline, week 2, and week 4. |