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NCT Number: NCT06926712

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

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.

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Key information

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin E

Drug

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

Primary outcomes

  1. the length of hospital stay

    Time frame: During the intervention

    The effect of vitamin E supplementation on the length of hospital stay in non-cyanotic cardiac pediatric patients with lower respiratory tract infections.

Secondary outcomes

  1. risk factors

    Time frame: During the intervention

    To assess the impact of identified risk factors (e.g., prematurity, malnutrition, severity of pneumonia, and different age groups) on hospital length of stay.

    • To determine the incidence of complications (e.g., need for ICU, mechanical ventilation, congestive heart failure) concerning identified risk factors.

Study contacts

Contact information is provided by the study sponsor or research team.

safaa ahmed, master

CONTACT

[email protected]

01016896337

safaa ahmed, master

CONTACT

[email protected]

01016896337

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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