Catch up Growth Of Children After Closure Of Hemodinamically Significant Large VSD In Assuit University Children Hospital

March 31, 2026 updated by: Faten Samir Malak Nashed, Assiut University

The primary objective of this study is to evaluate the patterns of catch-up growth in children following the closure of large VSDs.

• Specific Objectives:

  • To measure anthropometric changes (Weight, Height/Length, and BMI) pre- and post-closure.
  • To determine the time interval required to reach normal growth percentiles for age and sex.
  • To identify predictors of poor growth recovery (e.g., age at intervention, baseline nutritional status, or residual shunts).

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Ventricular septal defect (VSD) is the most common congenital heart disease, representing 30% to 50% of cardiac malformations at birth. It can lead to pulmonary hypertension and congestive heart failure. A hallmark clinical manifestation in these children is Failure to Thrive (FTT). The growth failure is multifactorial, resulting from increased metabolic demands (tachycardia and increased respiratory effort), inadequate caloric intake due to fatigue during feeding, chronic tissue hypoxia, and frequent lower respiratory tract infections.

Surgical closure eliminates the left-to-right shunt; restoring hemodynamic stability, reducing energy demands, improving feeding tolerance, and providing a substrate for growth recovery. Surgical correction in the first months of life is the current option for most large VSDs, as it provides complete resolution of the cardiac anomaly, with earlier control of heart failure, allowing for earlier cardiovascular drug weaning.

Although low weight at the time of repair is a known risk factor for morbidity and mortality, early surgery leads to a more favorable growth pattern. In fact, growth normalization of infants with VSD and normal birth weight who underwent primary surgical closure before the first year of life has been documented. Some reports emphasize the importance of early surgical repair for the best growth patterns in these infants. These benefits have also been observed in low birth weight infants, although with more limited growth acceleration, probably due to an early intrauterine insult. Early surgery also provides a shorter period of time at risk of heart failure complications, including respiratory infections, need for medication, and hospitalization. However, in some centers, surgery is delayed until a higher weight is achieved to reduce operative risks. The phenomenon of catch-up growth-an acceleration of growth following removal of the growth-limiting condition-is well-described in pediatric surgical literature but varies in magnitude and timing after VSD closure.

The study aims at establishing the pattern of catch-up growth in infants who have undergone surgical repair of VSD before 1 year of age and comparing it with the reference population. The research also evaluates the influence of the severity of preoperative growth failure on the postoperative growth pattern in term and preterm infants.

Study Type

Observational

Enrollment (Estimated)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71515
        • Assiut University Children Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The population includes:

Age group: Infants and young children aged from 1 month up to 2 years. Clinical Status: Patients presenting with symptoms of congestive heart failure and Failure to Thrive (FTT) due to the left-to-right shunt.

Surgical Status: Patients who are candidates for and undergo successful surgical or interventional closure of the defect.

Nutritional Status: Children exhibiting pre-operative growth retardation (low weight-for-age or height-for-age Z-scores) specifically related to their cardiac condition.

Description

Inclusion Criteria:

  • Children diagnosed with isolated large VSD meeting the following criteria:
  • Age from 1 month to 2 years old
  • Symptomatic patient with hemodynamically significant VSD by echocardiography who is candidate for closure.
  • Patients with pre-operative growth retardation
  • Patients undergoing successful closure

Exclusion Criteria:

  • Associated complex heart lesions or cyanotic CHD (e.g., Tetralogy of Fallot).
  • Genetic syndromes affecting growth (e.g., Down syndrome , Turner syndrome)
  • Major extra-cardiac malformations or chronic systemic diseases (e.g., Renal failure,liver disease, metabolic disorder, Celiac disease).
  • Preoperative malnutrition unrelated to cardiac disease (e.g., malabsorption syndromes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Weight-for-Age Z-score (WAZ)
Time Frame: Baseline, 6, 12, and 18 months post-closure.
Assessment of catch-up growth by measuring the change in Weight-for-Age Z-scores.
Baseline, 6, 12, and 18 months post-closure.
Change in Height-for-Age Z-score (HAZ)
Time Frame: Baseline, 6, 12, and 18 months post-closure.
Assessment of catch-up growth by measuring the change in Height-for-Age Z-scores
Baseline, 6, 12, and 18 months post-closure.
Change in Weight-for-Height Z-score (WHZ
Time Frame: Baseline, 6, 12, and 18 months post-closure
Assessment of catch-up growth by measuring the change in Weight-for-Height Z-scores.
Baseline, 6, 12, and 18 months post-closure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Catch up Growth Of Children

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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