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CTRI Number  CTRI/2025/10/096604 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 28/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Giving mothers m-Health application ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness mHealth application on mothers knowledge, satisfaction on home based newborn care and growth, development of neonates after discharge from NICU. 
Scientific Title of Study   Effectiveness of m-Health application "Sishu Suraksha" on maternal knowledge, satisfaction with home care practices and clinical outcomes, growth and development of high-risk neonates following NICU discharge from a selected tertiary care hospital: 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  Manisha Praharaj 
Designation  Assistant Professor 
Affiliation  SOA deemed to be university 
Address  vipul garden appartment, tower- 8, 701. Ghatikia, Bhubneswar, Khordha
SUM Nursing College campus 2, Ghatikia, Bhubneswar, Khordha Pin - 751003
Khordha
ORISSA
751003
India 
Phone  9937463998  
Fax    
Email  manishapraharaj21486@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pravati Tripathy 
Designation  Director 
Affiliation  SOA deemed to be university 
Address  SUM Nursing College campus 2, Ghatikia, Bhubneswar, Khordha Pin - 751003

Khordha
ORISSA
751003
India 
Phone  9437035927  
Fax    
Email  pravati.tripathy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manisha Praharaj 
Designation  Assistant Professor 
Affiliation  SOA deemed to be university 
Address  vipul garden appartment, tower- 8, 701. Ghatikia, Bhubneswar, Khordha
SUM Nursing College campus 2, Ghatikia, Bhubneswar, Khordha Pin - 751003
Khordha
ORISSA
751003
India 
Phone  9937463998  
Fax    
Email  manishapraharaj21486@gmail.com  
 
Source of Monetary or Material Support  
Siksha O Anusandhan University campus - 2, Ghatikia, Kalinga Nagar Bhubneswar, Khurdha Pin - 751003 Odisha, India 
 
Primary Sponsor  
Name  Siksha O Anusandhan University 
Address  Siksha O Anusandhan University Campus 2, Ghatikia, Bhubaneswar Odisha, Pin - 751003, India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debasish Nanda  IMS & SUM Hospital  IMS & SUM Hospital Ghatikia, Bhubaneswar, pin - 751003
Khordha
ORISSA 		 9861422685

dedasishnanda@soa.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of medical sciences (IMS) and SUM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mothers of neonates discharged from NICU and willing to use mobile app. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Educational material (information booklet)  The control group: The control group will receive the standard post-discharge care through follow-up visits to the pediatrician and educational materials (information booklet) but will not use the m-Health app. The mothers will be given health education regarding newborn care at home before discharge and post test will be conducted during follow up visits. 
Intervention  m-Health app "Sishu Surakhya"  Intervention group: All the mothers for high risk neonates discharge from NICU will be selected and randomised by computer generated numbers. The intervention group will receive the mHealth app “Sishu Surakhya”. The app will provide real-time educational content, video tutorials, and reminders about neonatal care, including feeding, hygiene, and developmental milestones. Mothers will be given health education regarding newborn care at home before discharge and app will be installed in their phone. training will be given to mothers how to use there app. the post test will be conducted during follow up visit. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  For Neonates:
High-risk neonates (Preterm infants and low birth weight infants) admitted to the NICU of a tertiary care hospital will be taken once they are hemodynamically stable and ready for discharge.

For mothers:
Mothers of high-risk neonates who have been discharged from NICU and are willing to give consent

 
 
ExclusionCriteria 
Details  For mothers
Mothers who cannot read and speak English or the local language, Odia.
Mothers who do not have smartphones
Mothers who are critically ill and cannot take care of their neonates.
For Neonates:
All term neonates
All high risk neonates who can not be managed at home
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maternal knowledge, satisfaction, neonatal clinical outcomes, growth and development  one month, 3 months and 5 months 
 
Secondary Outcome  
Outcome  TimePoints 
Breast feeding rate, Kangaroo mother care/day, diaper change and sleep pattern of neonates  one month, 3 months and 5 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   01/12/2025 
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="0"
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   mHealth intervention is a web-based application for healthcare services in remote areas through interaction with healthcare professionals by enriching the network with the mothers and healthcare providers. Through the app, mothers of high-risk neonates will be empowered to care for their high-risk neonates at home after discharge from the NICU. The app will have a simple interface that will be easy to navigate. This app will help in monitoring neonate’s growth and development, health status after discharge from the hospital, immunization status, facilitating early recognition of danger signs and prompt referral, health information on breastfeeding, expression of breast milk and feeding, kangaroo mother care, hygiene practices including bath, massage and diaper care, complementary feeding, diaper change/day. All mothers of high-risk neonates will be selected, and Randomization will be done by using computer-generated sequences. The participants will be assigned to the experimental and control groups by sequentially numbered, opaque, sealed envelopes (SNOSE method) for allocation concealment.  The pre-test will be conducted the day before discharge, and mothers will be given health education regarding home care practices for high-risk neonates using appropriate audio-visual aids. The app will be installed on the participant’s mobile, and detailed instructions on the use and benefits of the app will be given to the participants. The post-test will be conducted at one month, 3 months, and 5 months after discharge. Data will be analyzed by using specific tests like repeated-measure ANOVA, mean, and SD.

 
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