The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections

Официальное название

The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections - Randomized Controlled Trial

Обзор

Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease. In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia. Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke. Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced. Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing. There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.

Подробное описание

Congenital heart disease can lead to serious health issues, particularly an increased risk of infections, specifically respiratory infections. Lower respiratory tract infections are the fifth leading cause of death globally. Also considered a significant cause of morbidity and mortality among children with congenital heart disease.

In Egypt, it is estimated that 10% of deaths in children under the age of 5 years are probably caused by lower respiratory tract infections and other acute respiratory infections. common non-cyanotic CHD like Ventricular septal defect predispose to bronchopneumonia.

Hemodynamically significant congenital heart disease with pulmonary congestion increases the risk of lower respiratory tract infections and hospitalizations. This relies on several modifiable risk factors, including low socioeconomic status, poor diet, overcrowding, prematurity, male gender, and exposure to secondhand smoke.

Micronutrients play a crucial role in strengthening the immune system. Many Studies have shown that when children are supplemented with various micronutrients, they experience fewer episodes of acute respiratory infections, and the duration and severity of these infections are reduced.

Vitamin E is essential for immune system function and may lower disease risk by enhancing immune responses. It protects neurons and respiratory mucosa from oxidative damage and has been linked to a reduced incidence of asthma and inflammation, potentially safeguarding young children from atopy and wheezing.

There are no available studies in our locality about the effect of vitamin E supplementation on the length of hospital stay for non-cyanotic cardiac patients with lower respiratory tract infections.

Вмешательства

• Препарат Vitamin E
  dose of vitamin E in an appropriate dose for age during hospital stay for intervention group

Первичные конечные точки

• the length of hospital stay [Срок оценки: During the intervention]

Вторичные конечные точки (1)

• risk factors [Срок оценки: During the intervention]

Критерии участия

Критерии включения

• Pediatric patients are diagnosed with non-cyanotic heart disease associated with severe lower respiratory tract infection. ⁃ The patients are aged 2 months to 5 years of both sexes.

Критерии исключения

• Pediatric patients that have other congenital anomalies other than CHD.

• Those with chronic respiratory diseases such as asthma, bronchiectasis, etc.).
• Immunocompromised patients, such as those who receive steroids or chemotherapy, etc.
• Pediatric patient that received vitamin E in the previous month.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• [1] M. M. Djer and D. B. S. , Emilda Osmardin, Badriul Hegar, "Increased Risk of Recurrent Acute Respiratory Infections in Children with Congenital Heart Disease: A Prospective Cohort Study," Indones. Biomed. J., vol. 12, no. 4, p. p.288-389, 2020, doi: 10.18585/inabj.v12i4.1262. [2] E. Kılıçoğlu and Z. Ü. Tutar, "Evaluation of Children with Congenital Heart Disease Hospitalized with the Diagnosis

Идентификаторы

NCT: NCT06926712 · safaa1451995protocol

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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