| CTRI Number |
CTRI/2026/02/104590 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Treatments to Improve Movement and Reduce Jaundice in Premature Babies |
|
Scientific Title of Study
|
Comparative Efficacy Of Vojta Versus Multimodal Stimulation On Neuromotor Behavior And Bilirubin Levels Among Preterm With Neonatal Jaundice: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yukta Ghugal |
| Designation |
Postgraduate Student (MPT – Neuro Physiotherapy) |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Datta Meghe Institute of Higher Education and Research (Deemed to be University)
Sawangi (Meghe), Wardha
Maharashtra
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7083763678 |
| Fax |
|
| Email |
yuktaghugal.pt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharath Hullumani |
| Designation |
Assistant Professor - Department of Paediatrics and Neonatal Physiotherapy |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Datta Meghe Institute of Higher Education and Research (Deemed to be University)
Sawangi (Meghe), Wardha
Maharashtra
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8660621272 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yukta Ghugal |
| Designation |
Postgraduate Student (MPT – Neuro Physiotherapy) |
| Affiliation |
Ravi Nair Physiotherapy College |
| Address |
Datta Meghe Institute of Higher Education and Research (Deemed to be University)
Sawangi (Meghe), Wardha
Maharashtra
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7083763678 |
| Fax |
|
| Email |
yuktaghugal.pt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education & Research |
| Address |
Datta Meghe Institute of Higher Education & Research (Deemed to be University)
Sawangi (Meghe),
Wardha – 442107,
Maharashtra, India. |
| 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 |
| Dr Irshad Qureshi |
Acharya Vinoba Bhave Rural Hospital NICU PICU DMIHER |
Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA |
9406010010
irshadphysio@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P590||Neonatal jaundice associated withpreterm delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multimodal Stimulation |
Preterm neonates with neonatal jaundice will receive structured multimodal stimulation along with standard medical care. The program will include auditory stimulation using mother voice tactile stimulation using gentle massage visual stimulation using black and white patterns and vestibular stimulation through gentle rocking. Each session will last for 20 minutes once daily for 7 days or until NICU discharge. Sessions will be supervised and stopped if the infant shows signs of stress or instability. |
| Intervention |
Vojta Therapy |
Preterm neonates with neonatal jaundice will receive Vojta therapy along with standard medical care. The intervention will be administered by a trained pediatric physiotherapist. Infants will be positioned in supine prone and side lying postures. Gentle peripheral pressure stimulation will be applied at specific trigger zones such as heel pectoral area and medial epicondyle to facilitate reflex locomotion patterns. Each session will last for 10 to 15 minutes and will be given once daily for 7 consecutive days or until NICU discharge. Vital signs including heart rate respiratory rate and oxygen saturation will be monitored continuously and the session will be stopped if any signs of distress are observed. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
Gestational Age: Preterm Infants born at less than equal to 37 weeks of gestation.
Age of enrolment: Infants diagnosed with Neonatal Jaundice within the first 7 days.
Bilirubin Levels: Infants with Elevated bilirubin levels requiring intervention, as determined by clinical guidelines.
Parental Consent: Written informed Consent obtained from parents or legal guardians.
Neurological status: Infants without congenital neurological abnormality, but at risk for neuromotor impairment due to prematurity |
|
| ExclusionCriteria |
| Details |
Severe Medical Conditions: Infants with severe congenital anomalies or genetic disorders.
Other Treatments: Infants receiving other forms of physical therapy or interventions that could affect neuromotor outcomes.
Severe Jaundice: Infants requiring exchange transfusion or intensive phototherapy beyond standard care.
Neurological Abnormalities: Infants diagnosed with major neurological conditions (e.g., hypoxic-ischemic encephalopathy, intracranial haemorrhage).
Infection: Infants with active infections or sepsis that might interfere with the study protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| APGAR |
Baseline day, 4Day,7 Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
INFANIB
Bilirubin level
Length of NICU stay and hospital stay
|
Baseline day, 4Day,7 Day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 randomized controlled trial aims to compare the effectiveness of Vojta therapy and multimodal stimulation on neuromotor behavior and bilirubin levels in preterm neonates with neonatal jaundice. Neonatal jaundice is common in preterm infants and may affect early neurological development. Conventional management mainly focuses on reducing bilirubin levels but does not address early neuromotor stimulation. Early physiotherapy interventions may support brain development and improve functional outcomes. In this study preterm neonates diagnosed with jaundice within the first week of life will be randomly assigned to receive either Vojta therapy or structured multimodal stimulation along with standard medical care. Neuromotor behavior and bilirubin levels will be assessed to determine the effectiveness of both interventions. The hypothesis of the study is that Vojta therapy and multimodal stimulation will improve neuromotor behavior and help in reducing bilirubin levels and one intervention may show better outcomes than the other. |