Prevalence Of Vitamin A Deficiency In Critically Ill Children With Sepsis And Its Association With Clinical Outcomes

NCT06391437 | Completed

• 1 other identifier: RC17-4-2023
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the work is to assess the prevalence of vitamin A deficiency in critically ill children with sepsis and the association between vitamin A deficiency and clinical outcomes

Conditions

Vitamin A Deficiency in Children

Outcome Measures

Primary Outcomes (2)

• Severity of sepsis in pediatric patients with vitamin A deficiency

  Severity of sepsis in pediatric patients with vitamin A deficiency

  1 month

• Clinical outcomes in septic pediatric patients with vitamin A deficiency

  Length of hospital stay and mortality rate in pediatric patients with vitamin A deficiency

  1 month

Study Arms (2)

Control group

Sex- and age-matched approximate-health children without sepsis will be recruited as a control group.

Diagnostic Test: Extraction of blood sample

Studied group

All pediatric Patients from 29 days to 16 years old who were admitted to the pediatric intensive care unit (PICU) with sepsis as defined by International pediatric sepsis consensus conference will be consecutively recruited in this study.

Diagnostic Test: Extraction of blood sample

Interventions

Extraction of blood sample DIAGNOSTIC_TEST

Blood samples will be collected from all patients during the first 24 h of admission before enteral nutrition and/ or parenteral nutrition.

Control group; Studied group

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective study will be conducted from May 2023 to October 2023 in pediatric intensive care unit (PICU) at Benha university Hospital

You may qualify if:

• All pediatric Patients from 29 days to 16 years old who were admitted to the pediatric intensive care unit (PICU) with sepsis as defined by International pediatric sepsis consensus conference will be consecutively recruited in this study.
• Sex- and age-matched approximate-health children without sepsis will be recruited as a control group.

You may not qualify if:

• \- Age \> 16 years old.
• \- Premature infants and low birth weight infants.
• \- Children with underlying organ dysfunction, having received chemotherapy or radiotherapy, hematological malignancies, primary or acquired immunodeficiency.
• \- Children who discharged against medical advice with an uncertain prognosis.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Cairo, 13511, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric and Neonatology

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: May 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 31, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

EG (1)