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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-5
SponsorAssiut University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin E

    Drug

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

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: interventionActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

the length of hospital stay

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

Time frame
During the intervention

Secondary outcomes

1

risk factors

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.

Time frame
During the intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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