| CTRI Number |
CTRI/2026/01/100659 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| 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
|
Early Care Intervention for early newborns |
|
Scientific Title of Study
|
Effectiveness of Early Developmental Stimulation Among Late Preterm Infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Revathi Ramendran |
| Designation |
Student |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy, AHS 4th floor, Saveetha Institute of Medical and Technical Sciences, Thandalam.
Chennai
TAMIL NADU
602105
India
Chennai
TAMIL NADU
602105
India |
| Phone |
7306752675 |
| Fax |
|
| Email |
revathiramendran0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anees Ahmed FM |
| Designation |
Lecturer |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy, AHS 4th floor, Saveetha Institute of Medical and Technical Sciences, Thandalam.
Chennai
TAMIL NADU
602105
India
Chennai
TAMIL NADU
602105
India |
| Phone |
9043965344 |
| Fax |
|
| Email |
fmanees04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Revathi Ramendran |
| Designation |
Student |
| Affiliation |
Saveetha College of Physiotherapy |
| Address |
Saveetha College of Physiotherapy, AHS 4th floor, Saveetha Institute of Medical and Technical Sciences, Thandalam.
Chennai
TAMIL NADU
602105
India
TAMIL NADU
602105
India |
| Phone |
07306752675 |
| Fax |
|
| Email |
revathiramendran0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha College of Physiotherapy, AHS 4th floor, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, India - 602105 |
|
|
Primary Sponsor
|
| Name |
Revathi Rameandran |
| Address |
Saveetha College of Physiotherapy, AHS 4th floor, Saveetha Institute of Medical and Technical Sciences, Thandalam, Chennai, India - 602105 |
| Type of Sponsor |
Other [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 Vignesh Srinivasan |
Saveetha Medical College and Hospital |
Department of Physiotherapy, 1st Floor, Paediatric Physiotherapy Unit, Thandalam, Chennai 602 105.
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
8760563032
vignesh.scpt@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL SCIENTIFIC REVIEW BOARD |
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 |
Early Developmental Stimulation (Oromotor Stimulation + Tactile-Kinesthetic Stimulation) |
Early Developmental Stimulation will be administered to late preterm infants born between 34 weeks and 36 weeks 6 days of gestation. The intervention will be initiated within the first 7 days of postnatal life, once the infant is medically stable. The protocol consists of two components: oromotor stimulation and tactile-kinesthetic stimulation, provided under NICU safety guidelines by trained neonatal physiotherapists.
Oromotor stimulation will be given to infants from 34 to 36 weeks gestational age to enhance sucking ability and oral motor coordination. The intervention includes gentle tactile stimulation of the lips, cheeks, gums, and tongue using a gloved finger to facilitate oral reflexes and improve feeding efficiency. This component will be administered for 5–7 minutes per session, when the infant is calm and alert.
Tactile-kinesthetic stimulation will be provided to promote muscle tone, sensory-motor integration, and motor development. This includes gentle tactile input and passive range of motion exercises of the upper and lower limbs with controlled flexion and extension movements. Kinesthetic stimulation will be administered for 10–15 minutes per session.
Each intervention session will last approximately 20 minutes, delivered five days per week. The intervention will be continued for a duration of up to six months or until hospital discharge, whichever occurs earlier. Vital signs including heart rate, respiratory rate, and oxygen saturation will be monitored before, during, and after each session. The intervention will be discontinued immediately if signs of physiological instability or distress are observed. |
| Comparator Agent |
Standard Routine Neonatal Care as per NICU Protocol |
Infants allocated to the control group will receive standard routine neonatal care as per the Neonatal Intensive Care Unit (NICU) and postnatal ward protocols of Saveetha Medical College Hospital. This routine care will be provided to late preterm infants born between 34 weeks and 36 weeks 6 days of gestation, starting from birth and continuing throughout the hospital stay.
Standard routine care includes regular medical and nursing management such as thermoregulation, monitoring of vital signs, nutritional support (breastfeeding, expressed breast milk, or gavage feeding as advised by the neonatologist), positioning for comfort and safety, infection prevention measures, and routine handling for medical and nursing procedures. No structured oromotor stimulation or tactile-kinesthetic developmental stimulation will be provided as part of the study intervention.
All infants in the control group will undergo routine developmental monitoring and follow-up assessments as per hospital policy. Outcome measures, including Hammersmith Infant Neurological Examination (HINE) and Gross Motor Function Measure (GMFM), will be assessed at the same time points as the intervention group to allow comparison between groups. No additional therapeutic stimulation beyond routine neonatal care will be administered. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Gestational age at birth between 34 weeks to 36 weeks 6 days (i.e., Late Preterm Infants).
Admitted to NICU or postnatal ward within the study hospital during the data collection period.
Postnatal age: Infants enrolled within first 7 days of life.
comparison between HINE Scoring and GMFM
|
|
| ExclusionCriteria |
| Details |
structural abnormalities
Infants with major congenital anomalies or known genetic syndromes (e.g., Down syndrome, Edward syndrome).
Recent surgeries.
Parents/guardians unwilling or unable to provide informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HINE Scoring |
Baseline (T0), 4 weeks (T1), 24 weeks (T2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GMFM |
Baseline (T0), 4 weeks (T1), 24 weeks (T2) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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="8"
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
|
Late preterm infants born between 34 and 36 weeks of gestation are at higher risk of delayed feeding growth and neurodevelopment due to physiological immaturity. Early developmental stimulation using oromotor and kinesthetic techniques may help improve sucking ability weight gain muscle tone and motor development during early life. This prospective experimental study aims to evaluate the effectiveness of early developmental stimulation among late preterm infants. A total of 50 infants will be selected using convenience sampling and divided into an intervention group receiving early developmental stimulation and a control group receiving routine neonatal care. The intervention will be initiated within the first week of life and continued for a specified duration with regular monitoring of vital signs. Outcomes will be assessed using neurological motor and growth parameters. The study is expected to demonstrate that early developmental stimulation is a safe feasible and effective method to enhance neurodevelopmental outcomes in late preterm infants. |