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CTRI Number  CTRI/2025/06/089442 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [nutritional]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of nutritional intervention on weight Gain in children with heart disease.  
Scientific Title of Study   Impact of intensified nutritional Intervention on Weight Gain in infants with unoperated congenital heart disease in age group between 0-6 months: 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  Dr Dinesh kumar 
Designation  consultant and head, department of paediatrics 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Room no- 277, 2nd floor, OPD building Department of paediatrics
ABVIMS and Dr RML Hospital
Central
DELHI
110001
India 
Phone  9868143132  
Fax    
Email  dineshkumar169@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh kumar 
Designation  consultant and head, department of paediatrics 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Room no- 277, 2nd floor, OPD building Department of paediatrics
ABVIMS and Dr RML Hospital
Central
DELHI
110001
India 
Phone  9868143132  
Fax    
Email  dineshkumar169@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Dinesh kumar 
Designation  consultant and head, department of paediatrics 
Affiliation  ABVIMS and Dr RML Hospital 
Address  Room no- 277, 2nd floor, OPD building Department of paediatrics
ABVIMS and Dr RML Hospital
Central
DELHI
110001
India 
Phone  9868143132  
Fax    
Email  dineshkumar169@yahoo.co.in  
 
Source of Monetary or Material Support  
ABVIMS and Dr RML Hospital 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital 
Address  ABVIMS and Dr RML Hospital 
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 Dinesh kumar  ABVIMS and Dr RML Hospital  Room no- 268, 2nd floor, OPD building Department of paediatrics
Central
DELHI 		 9868143132

dineshkumar169@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, ABVIMS, Dr RML Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group   The mother will be counselled to give at least 8-12 feeds per 24 hours and ad lib. For patient on top feed, volume of feed given is at least 120ml/kg/day by KS and ad lib. Patient with weight for height -3SD will be advised to give at least 100 Kcal/Kg/day 
Intervention  intensified nutritional intervention  Additional calories will be provided depending on nutritional state of patients. 1.Dietary plan A – given to infants with weight for height above -2 standard deviation on WHO growth standards. Total volume of feed required in the intervention group will be calculated with a target of 100 kcal/kg/day. Mothers will be counselled to provided 50-80% of total feed by EBM with Katori-spoon feeding; breastfeeding will be continued. 2.Dietary plan B – given to infants with weight for height between -2 to -3 standard deviation on WHO growth standards. Total calorie provided will be 110-120 Kcal/kg/day in additional to breastfeed. 3) Dietary plan C – given to infants with weight for height below -3 standard deviation on WHO growth standards. Total calorie provided will be 130-150 Kcal/kg/day in additional to breastfeed. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  4.00 Month(s)
Gender  Both 
Details  All infants less than 4 months of age with high nutritional risk cardiac lesion presenting to division of pediatric cardiology OPD with unoperated congenital heart disease. 
 
ExclusionCriteria 
Details  1. Failure to obtain consent
2. Non cardiac chronic conditions impacting growth eg. Inborn errors of metabolism, severe
Liver/Renal dysfunction
3. Prematurity (less than 37 wks)
4. Chronic diseases (cystic fibrosis, tuberculosis, HIV, Infective endocarditis)
5. Malabsorption
6. Syndromic infants
7. Patient requiring in-patient care at presentation
8. Patient already on milk fortified with sugar and MCT oil. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean Z score of weight for height of case and control at the end of study period will be compared.  baseline, 2nd week, 4th week and 6th week, 8th week  
 
Secondary Outcome  
Outcome  TimePoints 
Weight Gain Velocity between two groups  2 months  
To assess the frequency of lower respiratory tract infections and hospital admissions in control and
intervention group. 		 2 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   09/07/2025 
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 - 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 - 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 - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  on request from primary investigator email - dineshkumar169@yahoo.co.in

  6. For how long will this data be available start date provided 09-07-2025 and end date provided 09-07-2030?
    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  
Infants with congenital heart disease (CHD) are prone to have poor nutritional status which results in poor growth, recurrent infections and increased postoperative complication. There are consensus guidelines for optimizing nutritional status but there is lack of evidence. Through this study we aim to assess whether Intensified nutritional intervention improves weight gain in infants age group between 0-6 months with unoperated CHD.  All infants less than 4 months of age with high nutritional risk cardiac lesion presenting to division of pediatric cardiology OPD with unoperated CHD will be enrolled and randomized into 2 groups - control and intervention group. Baseline anthropometry data will be recorded. 
For Control group - The mother will be counselled to give at least 8-12 feeds per 24 hours, and ad lib breastfeeding will be given. For patient on top feed, volume of feed given is at least 120ml/kg/day by KS and ad lib. Patient with weight for height below -3SD will be advised to give at least 100 Kcal/Kg/day.
Intervention group – additional calories will be provided depending on the current nutritional state of the patient as described below. Additional calories will be provided by adding sugar and medium chain triglyceride (MCT) oil to the milk-based diet. If an infant is on breast feeding it will be continued.
  1. Dietary plan A – given to infants with weight for height above -2 standard deviation on WHO growth standards. Total volume of feed required in the intervention group will be calculated with a target of 100kcal/kg/day. Mothers will be counselled to provided 50-80 percent of total feed by EBM with Katori-spoon feeding, breastfeeding will be continued. 
  2. Dietary plan B – given to infants with weight for height between -2 to -3 standard deviation on WHO growth standards. Total calorie provided will be 110-120 Kcal/kg/day in additional to breastfeed. 
  3. Dietary plan C – given to infants with weight for height below -3 standard deviation on WHO growth standards. Total calorie provided will be 130-150 Kcal/kg/day in additional to breastfeed.
Patient will be followed every 14 days for a period of 2 months after enrollment.  Mean Z score of weight for height of case and control at the end of study period will be compared.
 
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