| CTRI Number |
CTRI/2023/07/055364 [Registered on: 19/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
longitudinal study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of growth in pre & 3 months post surgery of heart disease in children under 5 years of age |
|
Scientific Title of Study
|
Early growth trends of children under 5 years of age with congenital heart disease who have undergone corrective surgery - a longitudinal study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hershavardhini K |
| Designation |
MD PEDIATRICS |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belgaum
Belgaum KARNATAKA 590010 India |
| Phone |
8056764999 |
| Fax |
|
| Email |
harini.rohit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Veeresh Manvi |
| Designation |
Professor, Pediatric cardiology |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belgaum
Belgaum KARNATAKA 590010 India |
| Phone |
9164000009 |
| Fax |
|
| Email |
manviveeresh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hershavardhini K |
| Designation |
MD PEDIATRICS |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE hospital road, Belgaum
Belgaum KARNATAKA 590010 India |
| Phone |
8056764999 |
| Fax |
|
| Email |
harini.rohit@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEs DR Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, KLE University, Belgaum |
|
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Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College KLE University Belagavi |
| Address |
Department of Pediatrics, Jawaharlal Nehru Medical college, Nehru nagar, KLE Hospital road, Belgaum, Karnataka 590010 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hershavardhini K |
KLEs Dr Prabhakar Kore hospital |
Department of Paediatrics,Jawaharlal Nehru MEdical college,Belagavi Belgaum KARNATAKA |
8056764999
harini.rohit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Institutional Ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q210||Ventricular septal defect, (2) ICD-10 Condition: Q211||Atrial septal defect, (3) ICD-10 Condition: Q213||Tetralogy of Fallot, (4) ICD-10 Condition: Q250||Patent ductus arteriosus, (5) ICD-10 Condition: Q258||Other congenital malformations ofother great arteries, (6) ICD-10 Condition: Q212||Atrioventricular septal defect, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Children under 5 yrs of age with Congenital heart disease fit for corrective surgery
2.Children under 5 yrs of age with failure to thrive with heart disease |
|
| ExclusionCriteria |
| Details |
1.Children under 5 years of age undergoing palliative surgery.
2.Children under 5 years of age with congenital heart disease with with other co morbidities like proven chromosomal abnormalities such as downs syndrome, diagnosed with metabolic disorders like galactosemia and hypothyroidism, congenital anomalies that restrict oral feeding like cleft palate and cleft lip.
3.Children whose parents donot agree for followup.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the early growth trends of children with congenital heart disease who have undergone corrective surgery under 5 years of age.
|
The study will be completed in the span of 1 year |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To identify factors affecting growth in children with Congenital heart disease & analyse the short term effects of corrective surgery.
|
The study will be completed in 1 year |
|
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Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
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)
|
01/08/2023 |
| 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 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
|
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Brief Summary
|
Congenital heart disease is the most common congenital anomaly found in newborn and nearly 9 to 11 in 1000 newborns are born with cardiac anom- alies in India.[1].Atrial septal defect, ventricular septal defect, patent ductus arteriosus, are the most common congenital heart diseases.[2]
Malnutrition is a common cause of morbidity in such children[3-8]. The extent to which the preoperative nutritional status affects the post op growth is un- known. There may be various factors such as ethnicity, socioeconomic sta- tus, nutritional practices, other cultural and environmental factors that may affect the nutritional status of the child with congenital heart disease[9].
There are various studies showing that corrective surgery shows a significant improvement in growth parameters within 3 months of post surgery{9-11]. However, studies have also shown that postoperative catch-up growth was less pronounced or even absent in 15%-50% of patients depending on the study[8,13]. The factors affecting growth in a child with congenital heart dis- ease may vary worldwide and hence there is a need to assess growth in these children in local conditions. The understanding and prevention of the effect of CHD on patients’ growth and development status in developing countries still needs improvement[11].
This study Is aimed at analysing the early growth trends of children pre and post operatively and factors affecting growth in this region of the country. This study also emphasises the importance of nutritional and growth as- sessment preoperatively so as to predict the early catchup growth post sur- gical correction. |