Clinical trial NCT06926712: The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections
Official title: The Effect of Vitamin E Supplementation on Hospital Stay Duration in Non-cyanotic Heart Disease Children With Lower Respiratory Tract Infections - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Respiratory Disease
Keywords: RTI-VIT E- CHD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 260
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the length of hospital stay
timeFrame: During the intervention
Secondary outcomes:
measure: risk factors
timeFrame: During the intervention
Other outcomes:
Locations:
Study officials:
References:
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