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CTRI Number  CTRI/2024/12/077967 [Registered on: 11/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study feeding problems in children with cerebral palsy under five years of age. 
Scientific Title of Study   Feeding problems in children with cerebral palsy under five years of age 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Charumathi S T 
Designation  Post Graduate Resident 
Affiliation  Maulana Azad Medical College 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi

Central
DELHI
110002
India 
Phone  6369763652  
Fax    
Email  drcharumathi98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monica Juneja 
Designation  Director Professor  
Affiliation  Maulana Azad Medical College 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi

Central
DELHI
110002
India 
Phone  9968604311  
Fax    
Email  drmonicajuneja@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Monica Juneja 
Designation  Director Professor  
Affiliation  Maulana Azad Medical College 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi


DELHI
110002
India 
Phone  9968604311  
Fax    
Email  drmonicajuneja@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg,near Delhi gate,Maulana Azad Medical College campus,Balmiki Basti, New Delhi, Delhi, 110002, India 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  2,Bahadur Shah Zafar Marg, New Delhi - 110002 
Type of Sponsor  Government medical college 
 
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 Charumathi S T  Maulana Azad Medical College and associated Lok Nayak Hospital  Ward 15,Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital.
Central
DELHI 		 6369763652

drcharumathi98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committe,Maulana Azad Medical College  Approved 
Institutional Ethics Committee,Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G809||Cerebral palsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Month(s)
Age To  60.00 Month(s)
Gender  Both 
Details  Children of either sex diagnosed with cerebral palsy aged 18 to 60 months accompanied by the primary caregiver. 
 
ExclusionCriteria 
Details  1.Children with anatomical abnormalities or diagnosed congenital defects which can impair feeding independently. For example: cleft lip, cleft palate, congenital heart disease, hiatal hernia
2.Children with acute illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of children with cerebral palsy having feeding problems.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of children with different severity levels of feeding problem on Eating and Drinking Ability Classification System (EDACS)  1 year 
Association of the level of feeding problem on EDACS with 1. Nutritional Status (weight for height Z-Score and Mid Upper Arm Circumference) (MUAC) 2. WHO QOL BREF score (quality of life scoring) 3. Level of GMFCS (Gross motor function classification system) 4. Level of CFCS (Communication function classification system) 5. CBCL score (behavioural Problems)  1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/12/2024 
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   Cerebral palsy is associated with myriad of feeding problems, like drooling, inadequate lip closure, swallowing, difficulties, and prolonged feeding.
About 53.5 % of children with cerebral policy had feeding problems, according to recent systematic review and meta analysis and those with higher GMFCS level were associated with increased difficulties in feeding.
Feeding problems are associated with increased risk of dehydration, malnutrition, aspiration, pneumonia, and poor quality of life.
in the study, the prevalence of feeding problems in children with cerebral policy between 18 and 60 months of age and their severity levels will be studied using EDACS.
in the study children with cerebral palsy between 18 and 16 months of age will be studied for the prevalence of feeding problems, and if present, the children will be provided appropriate, dietary counselling and interventions as per unit protocol.
 
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