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CTRI Number  CTRI/2025/11/096908 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nursing interventions ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Exploring the impact of Nursing Interventions in Managing Feeding Difficulties in Children with Cerebral Palsy 
Scientific Title of Study   Effect of Nursing Interventions on Feeding Difficulties of Children with Cerebral Palsy: 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  Priyanka Gudannawar 
Designation  Senior Tutor  
Affiliation  KAHER, Belagavi 
Address  KLE Institute of nursing sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
591108
India 
Phone  8904976510  
Fax    
Email  priyanka@kleunursingbgm.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr.Gavishiddhayya Salimath  
Designation  Professor and Head  
Affiliation  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH  
Address  Dept. of Child Health Nursing KLE Institute of nursing sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
591108
India 
Phone  7892976950  
Fax    
Email  gavisalimath@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Gudannawar 
Designation  Senior Tutor  
Affiliation   
Address  KLE Institute of nursing sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
591108
India 
Phone  8904976510  
Fax    
Email  priyanka@kleunursingbgm.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research KAHER 
Address  KAHER Institute of Nursing Sciences, NEHRU NAGAR, Belagavi 590010 Karnataka 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 Gavi Salimath   Dr. Prabhakar Kore Hospital and research centre  Chid Development Clinic, Dept. of Pediatric Neurology Second Floor, Nehru nagar, Belagavi 590010 Karnataka, India
Belgaum
KARNATAKA 		 8904976510

priyanka@kleunursingbgm.edu.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER Ethical committee (Human) for Ph D Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F82||Specific developmental disorder ofmotor function,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nursing intervention  6 sessions of 45 mins every 15 days for 3 months. It includes training on spoon feeding, biting, chewing, cup drinking, swallowing, and drooling during eating in children. 
Comparator Agent  Routine care  Routine care provided in hospital  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with cerebral palsy Aged 3-12 years
Children with cerebral palsy Classified as Gross Motor Function Classification System Levels 2-4
Children with cerebral palsy having feeding difficulties
 
 
ExclusionCriteria 
Details  Children with cerebral palsy classified as GMFCS Level V
Children with cerebral palsy who have frequent or uncontrolled seizures
Children with profound hearing loss not corrected with aids or cochlear implants leading to major communication barriers during feeding therapy
Children with cerebral palsy who are intellectually disable who have autism ADHD
Other comorbid conditions affecting feeding Cleft palate GI anomalies
Mothers or the primary caregivers with a history of diagnosed psychiatric illness like
schizophrenia major depression or who are currently under psychiatric treatmen
Mothers or the primary caregivers with speech or hearing disabilities that make
communication difficult during the sessions.
Mothers or the primary caregivers who are not living with the child full-time or are not
involved in feeding the child
Mothers or the primary caregivers who are currently enrolled in another clinical trial or
similar intervention program 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intervention group will show significant reduction in the feeding difficulties  1 week and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Intervention group will show significant increase in BMI after administering the nursing interventions  1st month and 3rd month 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) - 
  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyanka@kleunursingbgm.edu.in].

  6. For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomised controlled trial to see the impact of Nursing interventions on feeding difficulties in children with cerebral palsy. The sample size is 124 children with cerebral palsy who have feeding difficulties. Nursing intervention will be administered to the experimental group for over 6 sessions over the period of 3 months. The primary outcome  improvement in feeding difficulties and secondary outcome Body mass index is assessed after 3 months.   
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