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CTRI Number  CTRI/2025/12/098355 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [OCCUPATIONAL THERAPY]  
Study Design  Other 
Public Title of Study   Can the SENSE Program Help Preemie Babies in Mumbai’s NICU? 
Scientific Title of Study   The Feasibility of Implementing SENSE Program for Preterm Infants in the Neonatal Intensive Care Unit (NICU) In Public Hospital at Mumbai: A Pilot 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  Hemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  Occupational Therapy School and Centre, Seth GSMC and KEM Hospital 
Address  Occupational Therapy School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  nandgaonkar.hemant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Himanshi Raghani 
Designation  PG student 
Affiliation  Occupational Therapy School and Centre, Seth GSMC and KEM Hospital 
Address  Occupational Therapy School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8830387437  
Fax    
Email  himanshiraghani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hemant Nandgaonkar 
Designation  Assistant Professor 
Affiliation  Occupational Therapy School and Centre, Seth GSMC and KEM Hospital 
Address  Occupational Therapy School and Centre, Seth GSMC and KEM Hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9819660953  
Fax    
Email  nandgaonkar.hemant@gmail.com  
 
Source of Monetary or Material Support  
Occupational therapy school & training centre, KEM Hospital, Parel, India - 400012 
 
Primary Sponsor  
Name  Non sponser 
Address  NIL 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
HEMANT NANDGAONKAR  Seth GS Medical College  Occupational therapy department, 412, KEM HOSPITAL
Mumbai
MAHARASHTRA 
9819660953

nandgaonkar.hemant@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-2 Seth GS Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  SENSE Program  As per guidlines of SENSE program. Duration: from admission till discharge  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  3.00 Month(s)
Gender  Both 
Details  1. Preterm infants admitted at NICU whose gestational age less than 37 weeks .
2. Newly admitted infants
3. Both male and female infants.
 
 
ExclusionCriteria 
Details  1. Infants born with congenital anomalies ( Downs syndrome, spina bifida ,cleft palate , etc.)
2. Parents having any other psychiatry condition, neurological condition or any other disability
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
APIB
Hammersmith Neonatal Neurological Examination
• Maternal Confidence Questionnaire
 
during discharge from NICU
 
 
Secondary Outcome  
Outcome  TimePoints 
nil   
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/12/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [nandgaonkar.hemant@gmail.com].

  6. For how long will this data be available start date provided 12-02-2025 and end date provided 12-02-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

TITLE:

The Feasibility of Implementing SENSE Program for Preterm Infants In The Neonatal Intensive Care Unit (NICU) In Public Hospital At Mumbai: A Pilot Study

RATIONALE:

Preterm birth is associated with a range of neurodevelopmental challenges, including cognitive, motor, and sensory impairments. The NICU environment, while necessary for medical care, can be overwhelming and stressful for infants potentially disrupting their development. To address these challenges, the SENSE program was developed as a non-pharmacological intervention by providing developmentally appropriate sensory experiences. But there are limited studies showing the effect of SENSE program in neurodevelopmental and feeding outcomes in preterm infants. Presently, it is not used in our tertiary care hospital.  Before making it as Standard of Care, we would like to know the feasibility of SENSE program in Public Hospital at Mumbai.

 

AIM OF THE STUDY:

To evaluate the feasibility of implementing SENSE Program to increase positive sensory exposure for infants born preterm, support neonatal neurodevelopment, and increase maternal confidence.

OBJECTIVES:

1.Administration of SENSE program in tertiary care hospital from admission of the eligible candidate in the NICU.

2. To evaluate preterm infants by using APIB before and after the administration of SENSE.

3.To evaluate outcome of preterm infants by using a standardized scale Hammersmith Neonatal Neurological Examination(HNNE) at NICU in 37 – 40 weeks.

4.  To evaluate parent-infant attachment and parental stress levels by using Maternal Confidence Questionnaire pre and post administration of SENSE .

5.To analyze a qualitative feedback from nurses of NICU.

 

METHODOLOGY:

 

Study Design: Pilot study.

Study Duration: 18 months

Study Setting: Data

Sampling Technique: Purposive Sampling

Sample Size: As this is a Pilot Study, the sample size would be 20.

INCLUSION CRITERIA:

  1. Preterm infants admitted at NICU whose gestational age less than 37 weeks .
  2. Newly admitted infants
  3. Both male and female infants.

 

EXCLUSION CRITERIA:

  1. Infants born with congenital anomalies ( Downs syndrome, spina bifida ,cleft palate , etc.)
  2. Parents having any other psychiatry condition, neurological condition or any other disability

 

DATA COLLECTION:

 

 Permissions: After IEC approval,

1. Participants will be recruited based on inclusion and exclusion criteria.

 2. Consent /assent will be taken from caregivers.

 In this study there will be a single group, pre-post experimental study design

Data Gathering: Data will be collected from patients admitted in NICU.

 Assessment will be done using: 1.APIB(Assessment of preterm infant behaviour)

2.Maternal confidence questionnaire

SENSE program will be administered by

·       Individualized approach

·       Family centered approach

Ø  Parents will be provided weekly log books in which they will be asked questions such as amount of sensory exposures, by whom sensory exposures was given.

Ø  During the study,a qualitative feedback will be taken from nurses.

Ø  Just prior to discharge or on term age, HNNE will be administered as an outcome measure.

 
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