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CTRI Number  CTRI/2025/05/087864 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 28/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive 
Study Design  Single Arm Study 
Public Title of Study   Feeding problems its impact and challenges Faced by parents of children With Cerebral Palsy : A study At Pediatrics OPD AIIMS DELHI  
Scientific Title of Study   A Descriptive study to explore the feeding problems, its impact and challenges faced by parents of children with cerebral palsy at AIIMS, DELHI. 
Trial Acronym  N/A 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gunjan Chaudhary 
Designation  MSc. Nursing Student  
Affiliation  College of Nursing, All India Institute of Medical Sciences, New Delhi 110029 
Address  Porta Cabin 2 College of Nursing All India Institute Of Medical Sciences Ansari Nagar New Delhi

South
DELHI
110029
India 
Phone  8851356401  
Fax    
Email  gunjandwarka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Cecilia MS 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room NO 5, College of Nursing , All India Institute Of Medical Sciences, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9899187056  
Fax    
Email  cecilia.aiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ms Cecilia MS 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room NO 5, College of Nursing , All India Institute Of Medical Sciences, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9899187056  
Fax    
Email  cecilia.aiims@gmail.com  
 
Source of Monetary or Material Support  
College of Nursing All India Institute of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  Gunjan Chaudhary 
Address  Porta Cabin 2 College of Nursing All India Institute Of Medical Sciences Ansari Nagar New Delhi- 110029 
Type of Sponsor  Other [Self] 
 
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 Sheffali Gulati  All India Institute of Medical Sciences New Delhi   Pediatric OPD, Second floor, RAK OPD building, All India Institute of Medical Sciences New Delhi
South
DELHI 		 9810386847

Sheffaligulati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS NEW DELHI   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Parents of children with Cerebral Palsy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Parents of children diagnosed with cerebral palsy.
Parents who gives consent to participate in the study .
Parents who understands English or Hindi language in which the study tools are provided.

 
 
ExclusionCriteria 
Details  Parents of child with other life-threatening medical condition that significantly affects feeding .
Parents who are not willing to participate in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feeding problems  at the time of recruitment 
 
Secondary Outcome  
Outcome  TimePoints 
Anthropometric measurements & nutritional status.  Immediate assessment of outcome 
 
Target Sample Size   Total Sample Size="370"
Sample Size from India="370" 
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)   01/08/2025 
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="0"
Months="3"
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-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 30-11-2026 and end date provided 19-07-2031?
    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   A descriptive study conducted with an aim to explore the feeding problems , it’s impact and challenges faced by parents of children with cerebral palsy. The research approach is quantitative. Sample population for the study is parents of children with cerebral palsy. Study design is Descriptive. Primary objective is to explore the feeding problems faced by parents of children with cerebral palsy. Secondary objectives are to assess the impact of feeding problems and challenges faced by parents of children with cerebral palsy. Data collection will be done by a feeding and swallowing questionnaire, WHO growth charts, anthropometric measurements. Data will be collected over a period of three month. Descriptive statistics will be used for measuring prevalence and inferential statistics to explore feeding problems faced by parents of children with cerebral palsy.   
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