| CTRI Number |
CTRI/2024/12/078619 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| 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
|
Mothers and health care training in neonates with respiratory distress syndrome |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Health Care Delivery by Mothers Versus Trained Health Care Workers in Adjunct to Vojta Therapy on Clinical Outcomes in Neonates with Respiratory Distress Syndrome: A Randomized Controlled 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 |
Dr Sharath Hullumani V |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Ground Floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Swangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9964066927 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Irshad Qureshi |
| Designation |
Professor, Principal |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Ground Floor, Department of Neuro Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Swangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9406010010 |
| Fax |
|
| Email |
irshadphysio@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharath Hullumani V |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Ground Floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Swangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9964066297 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe, 442001, Wardha, Maharasthra, India
|
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research DU |
| Address |
Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha -442001
|
| 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 Sharath Hullumani V |
Acharya Vinoba Bhave Rural Hospital |
Room No.19, 2nd Floor, Neonatal Intensive Care Unit(NICU), Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research (DU),Sawangi Meghe
Wardha
MAHARASHTRA |
9964066927
sharathhullumani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Deemed to be University Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P84||Other problems with newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Trained Health Care Worker+Maternal Participation in Health Care |
includes multimodal stimulation daily infant development technique, following training from the paediatric physiotherapist. After training mothers and health care worker are assessed using the maternal participation and skills evaluation form, with a requirement to score 9 marks or more for participation; otherwise, they receive retraining and re-evaluation. This regimen continues until discharge.
Duration-4weeks |
| Comparator Agent |
Vojta |
The reflex roll from the supine position—Phase I, from side decubitus; phase II, III, and IV, with reflex activation of two or three points.
Health Care Delivery by Mothers and Trained Health Care Worker includes multimodal stimulation daily infant development technique, following training from the paediatric physiotherapist. After training mothers and health care worker are assessed using the maternal participation and skills evaluation form, with a requirement to score 9 marks or more for participation; otherwise, they receive retraining and re-evaluation. This regimen continues until discharge.
Duration-4weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
a) Preterm birth less than 36 weeks of gestational age.
b) Clinical diagnosis of NRDS
C) Spontaneously breathing neonates not requiring invasive mechanical ventilation at the time of enrolment.
d) Presence of respiratory distress defined by a Silverman Andersen score between one and seven (mild to moderate respiratory distress)
e) Hemodynamically stable at the time of enrolment.
g) Expected NICU stay of atleast 20 days to allow completion of the intervention protocol
h) The mother and the assigned health care provider must achieve a competency score of nine by ten on a standardised skill assessment conducted by a pedaitric physiotherapist following structured training. |
|
| ExclusionCriteria |
| Details |
Significant Congenital Abnormalities and profound Hemodynamic Instability
b) Life-Threatening Situations: Neonates with urgent and critical medical conditions other
than NRDS, necessitating immediate interventions, may be ineligible.
c) Serious Neurological Complications: Neonates with severe neurological issues that could
independently affect neuromuscular function, apart from NRDS, may be excluded.
|
|
|
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 |
Silverman-Anderson Respiratory Severity Score (RSS)
ii. Bayley Scale of Infant development |
Baseline
At the end of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral motor assessment scale |
Baseline
At the end of discharge |
|
Target Sample Size
Modification(s)
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
15/01/2025 |
| 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)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sharathhullumani@gmail.com].
- For how long will this data be available start date provided 18-12-2024 and end date provided 12-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Neonatal respiratory distress syndrome (NRDS) has both short-term and long-term complications for newborns. Neurodevelopmental delay is another complication of RDS, especially with infants who received mechanical ventilation [1]. The incidence of cerebral palsy also was increased in infants with RDS, with decreasing incidence as gestational age increased. The length of time on mechanical ventilation correlates with increased rates of both cerebral palsy and neurodevelopmental delay [1-3]. NRDS is a significant health concern for preterm infants in India, with prevalence rates ranging from 10% to 50% and affecting approximately 0.96% to 12% of live births. The incidence of NRDS is about 6.7% among newborns, with a notably higher rate of 30% among premature infants. |