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

Обзор

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).

Подробное описание

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.

Первичные конечные точки

• Change in Weight-for-Age Z-score (WAZ) [Срок оценки: Baseline, 6, 12, and 18 months post-closure.]
• Change in Height-for-Age Z-score (HAZ) [Срок оценки: Baseline, 6, 12, and 18 months post-closure.]
• Change in Weight-for-Height Z-score (WHZ [Срок оценки: Baseline, 6, 12, and 18 months post-closure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Египет · 1 центр

• Assiut University Children Hospital — Asyut

Публикации

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• Ortiz-Prado E, Henriquez-Trujillo AR, Rivera-Olivero IA, Lozada T, Garcia-Bereguiain MA; UDLA-COVID-19 team. High prevalence of SARS-CoV-2 infection among food delivery riders. A case study from Quito, Ecuador. Sci Total Environ. 2021 May 20;770:145225. doi: 10.1016/j.scitotenv.2021.145225. Epub 2021 Jan 17. PMID 33513511
• Galeotti C. [Mevalonate kinase deficiency]. Rev Prat. 2023 Oct;73(8):850-854. French. PMID 38354005

Идентификаторы

NCT: NCT07515248 · Catch up Growth Of Children

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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