| CTRI Number |
CTRI/2025/03/083204 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Maternal education and lactation support by counselling] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Breastfeeding practices and Interventions to Help the Same in Babies with Heart Disease After Cardiac Surgery |
|
Scientific Title of Study
|
Systematic study if breastfeeding practices in infants with Congenital Heart Diseases (CHD) and effectiveness of implementation of tailored interventions to improve breastfeeding outcomes- A Prospective Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naimisha Yenduri |
| Designation |
Senior Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 1, Floor 5, Department of Pediatric Cardiology,
Ernakulam
KERALA
682041
India |
| Phone |
08110847559 |
| Fax |
|
| Email |
naimishay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. R. Krishna Kumar |
| Designation |
HOD |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 1, Floor 5, Department of Pediatric Cardiology,
Amrita Institute of Medical Sciences, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
09895092746 |
| Fax |
|
| Email |
kumar_rk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Naimisha Yenduri |
| Designation |
Senior Resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 1, Floor 5, Department of Pediatric Cardiology,
Ernakulam
KERALA
682041
India |
| Phone |
08110847559 |
| Fax |
|
| Email |
naimishay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences, Tower 1, Floor 5, Department of Pediatric Cardiology, Ponekkara, Kochi, Kerala, 682041 |
| PCSI Research Grant 2023-24, PCSI Head office, 7th Floor, Room No. 29 Department of Cardiology All India Institute of Medical Sciences | New Delhi, India 110 029 |
|
|
Primary Sponsor
|
| Name |
Pediatric Cardiac Society of India PCSI |
| Address |
PCSI Head Office, 7th Floor, Room 29, AIIMS, New Delhi, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naimisha Yenduri |
Amrita Institute of Medical Sciences |
Tower 1, Floor 5, Department of Pediatric Cardiology,
Amrita Institute of Medical Sciences, Kochi, Kerala
Ernakulam
KERALA |
08110847559
naimishay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q20||Congenital malformations of cardiac chambers and connections, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactation support package |
personalized lactation support, educational materials in local languages, and trained lactation counselors guiding mothers through the perioperative period. Duration of intervention - from Admission to discharge. |
| Comparator Agent |
N/A; single arm |
N/A; single arm |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
1. Infants and neonates, born at term gestation diagnosed with Congenital heart disease, planned for corrective or palliative surgery.
2. Infants with mothers who are willing to breastfeed.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Time to restart feeds after cardiac surgery
2. Percentage of mothers directly breastfeeding at discharge
3. Infant weight at admission, discharge and 1 month follow up |
1. Baseline- at the time of Admission
2. Immediate postop
3. At the time of discharge
4. 1 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Infant weight at admission, discharge and 1 month follow up |
admission, discharge and 1 month follow up |
|
|
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)
|
15/04/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective interventional study aims to improve breastfeeding outcomes in infants with congenital heart disease (CHD) undergoing cardiac surgery by implementing targeted interventions such as maternal education and structured lactation counseling. Building on prior research phases that identified breastfeeding challenges, this study systematically applies tailored interventions to all mother-infant dyads recruited in the study. These interventions include personalized lactation support, educational materials in local languages, and trained lactation counselors guiding mothers through the perioperative period. The study follows up with key outcome measures such as: - Time to establish full oral feeds postoperatively
- Proportion of mothers breastfeeding at discharge
- Infant weight gain trends
By addressing modifiable barriers and optimizing lactation support, this study aims to establish a model of care that enhances breastfeeding success and nutritional outcomes in CHD infants |