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Growth and Development in Children with Cardiac Intervention before the age of 5

Growth and Development in Children who underwent Cardiac Intervention before the age of 5 - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064119
Enrollment
120
Registered
2024-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q20-Q28- Congenital malformations of the circulatory system

Interventions

Control Intervention1: nil: nil

Sponsors

Dr Krishanu Sabyasachi Mukhopadhyay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients who underwent corrective Cardiac Surgery or Catheter based Intervention for Congenital Heart Disease before the age of 5 At the Time of enrollment, at least 1 year has elapsed since the last corrective procedure was performed on the child.

Exclusion criteria

Exclusion criteria: History of Birth Asphyxia or HIE. History of stormy neonatal period with exclusive focus on those who suffered from Severe Intracranial Hemorrhage Meningitis Neonatal Seizures Sepsis TORCH infection and Neonatal Hyperbilirubinemia requiring Exchange Transfusion Extreme Prematurity at birth less than 28 weeks of gestation Syndromic etiology of Congenital Heart Disease.

Design outcomes

Primary

MeasureTime frame
Neurodevelopmental assessment based on the developmental quotient and categorized into Normal Neurodevelopmentally- DQ greater than 85 Mild Neurodevelopmental Delay- DQ between 71 to 84 Severe Neurodevelopmental Delay DQ less than 70 Final Growth assessment will be based on the Z score for weight age- Normal Growth Mild Growth failure -1SD to -2SD Moderate Growth Failure -2SD to -3SD. Severe Growth Failure less than -3SD Timepoint: At Baseline

Secondary

MeasureTime frame
Positive or negative correlation of Growth Failure & Neurodevelopmental delay with other factors present in the study population.Timepoint: At Baseline

Countries

India

Contacts

Public ContactDr Krishanu Sabyasachi Mukhopadhyay

KMC, Manipal

pushpa.kini@manipal.edu9845289801

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026