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CTRI Number  CTRI/2021/01/030713 [Registered on: 22/01/2021] Trial Registered Prospectively
Last Modified On: 22/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of expressed breast milk and direct breastfeeding in children with heart disease. 
Scientific Title of Study   Weight gain in babies with congenital heart disease and increased pulmonary blood flow :Breastfeeding versus supplemental spoon feeding. An open labelled 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  Varsha Jangid 
Designation  Postgraduate Resident Doctor 
Affiliation  ABVIMS and Dr. RMLHospital , New Delhi 
Address  Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
New Delhi
DELHI
110001
India 
Phone  9660733339  
Fax    
Email  varshajangir8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dinesh Kumar Yadav 
Designation  Head Division of Pediatric Cardiology 
Affiliation  ABVIMS and Dr RML Hospital, New Delhi 
Address  Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
New Delhi
DELHI
110001
India 
Phone  9868143132  
Fax    
Email  dineshkumar169@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Varsha Jangid 
Designation  Postgraduate Resident Doctor 
Affiliation  ABVIMS and Dr RML Hospital, New Delhi 
Address  Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
New Delhi
DELHI
110001
India 
Phone  9660733339  
Fax    
Email  varshajangir8@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr RML Hospital, New Delhi 
 
Primary Sponsor  
Name  ABVIMS and Dr RML Hospital New Delhi 
Address  Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi 
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 
Varsha Jangid  ABVIMS and Dr RML Hospital, New Delhi  Department of Pediatrics, Division of Pediatric Cardiology ,ABVIMS and Dr RML Hospital, New Delhi
New Delhi
DELHI 		 9660733339

varshajangir8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr RML Hospital New Delhi Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Awaited 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q210||Ventricular septal defect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breastfeedind in babies  comparator group will be counselled to give breastfed to their babies. 
Intervention  Supplemental Spoon Feeding of Breastmilk  Intervention group will be counselled to give Supplemental Spoon Feeding of Breastmilk to their babies. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  5.00 Month(s)
Gender  Both 
Details  All infants with congenital heart disease with post tricuspid left to
right shunt with modified Ross score > 6

On full breastfeeding

Age at time of enrollment <5 months.

 
 
ExclusionCriteria 
Details  Mother not available for breastfeeding .

Infants with obstructive cardiac left to right shunt & complex
cardiac conditions.

Infants who have undergone any cardiac surgery.

Prematurity <37 weeks

Known non-cardiac chronic conditions which are likely to affect
growth including “ malignancy ,neuromuscular, respiratory ,renal,
gastrointestinal, immunodeficiency and metabolic , genetic,or
other congenital anomalies”.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Weight gain in grams during study period.

 		 Baseline, 2 weeks, 4 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Frequency of hospitalization during study period  at 2weeks, 4weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2021 
Date of Study Completion (India) 01/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Infants with congenital heart disease and increased pulmonary blood flow frequently have feeding difficulty and failure to thrive. They typically present with interrupted feeding, sweating during feeds and suck rest suck cycle. Ideally all infants less than 6 months of age should be exclusively breastfed. Breastfeeding is a energy requiring process and is believed to be more tiring to the infants than spoon feeding. Keeping this in mind babies with heart disease and increased pulmonary blood flow are sometime advised to give expressed breastmilk by spoon so as to decrease energy expenditure. This has not been tested objectively yet and there is no evidence to support this practice. We want to find out whether feeding an infant with supplemental spoon feeding of expressed breastmilk will lead to better weight gain compared to traditional breastfed alone in infants with acyanotic congenital heart disease with increased pulmonary blood flow.
Hypothesis for study is that Supplemental feeding of expressed breastmilk by katori-spoon will lead to better weight gain compared to those on breastfeeding in infants with acyanotic congenital heart disease with increased pulmonary blood flow.
 
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