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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06926712
Enrollment
260
Registered
2025-04-15
Start date
2025-06-30
Completion date
2026-06-30
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disease

Keywords

RTI-VIT E- CHD

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.

Interventions

DRUGVitamin E

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
risk factorsDuring the interventionTo 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.

Contacts

Primary Contactsafaa ahmed, master
s.ahmed2795@gmail.com01016896337
Backup Contactsafaa ahmed, master
safaaAM@aun.edu.eg01016896337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026