Quality of Life Among Children With Inborn Error of Immunity

NCT07262047 | Not Yet Recruiting

• 1 other identifier: Soh-Med-25-9-14MS
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, we aim to assess the QOL of pediatric IEI patients compared with healthy controls and to determine different factors affecting QOL in these patients.

Conditions

Primary Immunodeficiency

Outcome Measures

Primary Outcomes (1)

• Arabic version of PedsQL, version 4

  The tool is composed of 23 items that cover the following domains: physical, emotional, social, and school functioning. Each item is on a 5-point Likert scale ranging between 0 and 4 (0= never, 1= almost never, 2= sometimes, 3= often, 4= almost always). Scores are linearly transformed to a 0- to 100- point scale (4 = 0, 3 = 25, 2 = 50, 1 = 75, 0= 100) and higher scores reflect a better HRQOL.

  At enrollment

Interventions

Quality of Life Assessment OTHER

Administration of standardized quality-of-life questionnaires (e.g., PedsQL) to children with primary immunodeficiency and/or their caregivers.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with primary immunodeficiency who are followed at participating immunology clinics or hospitals.

You may qualify if:

• children from 6 years untill 18 years

You may not qualify if:

• failed to get a consent not appropriate age

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• Bousfiha A, Jeddane L, Al-Herz W, Ailal F, Casanova JL, Chatila T, Conley ME, Cunningham-Rundles C, Etzioni A, Franco JL, Gaspar HB, Holland SM, Klein C, Nonoyama S, Ochs HD, Oksenhendler E, Picard C, Puck JM, Sullivan KE, Tang ML. The 2015 IUIS Phenotypic Classification for Primary Immunodeficiencies. J Clin Immunol. 2015 Nov;35(8):727-38. doi: 10.1007/s10875-015-0198-5. Epub 2015 Oct 7.

  PMID: 26445875 BACKGROUND

• de Vries E, Driessen G. Educational paper: Primary immunodeficiencies in children: a diagnostic challenge. Eur J Pediatr. 2011 Feb;170(2):169-77. doi: 10.1007/s00431-010-1358-5. Epub 2010 Dec 18.

  PMID: 21170549 BACKGROUND

• Tangye SG, Al-Herz W, Bousfiha A, Cunningham-Rundles C, Franco JL, Holland SM, Klein C, Morio T, Oksenhendler E, Picard C, Puel A, Puck J, Seppanen MRJ, Somech R, Su HC, Sullivan KE, Torgerson TR, Meyts I. Human Inborn Errors of Immunity: 2022 Update on the Classification from the International Union of Immunological Societies Expert Committee. J Clin Immunol. 2022 Oct;42(7):1473-1507. doi: 10.1007/s10875-022-01289-3. Epub 2022 Jun 24.

  PMID: 35748970 BACKGROUND

• Picard C, Al-Herz W, Bousfiha A, Casanova JL, Chatila T, Conley ME, Cunningham-Rundles C, Etzioni A, Holland SM, Klein C, Nonoyama S, Ochs HD, Oksenhendler E, Puck JM, Sullivan KE, Tang ML, Franco JL, Gaspar HB. Primary Immunodeficiency Diseases: an Update on the Classification from the International Union of Immunological Societies Expert Committee for Primary Immunodeficiency 2015. J Clin Immunol. 2015 Nov;35(8):696-726. doi: 10.1007/s10875-015-0201-1. Epub 2015 Oct 19.

  PMID: 26482257 BACKGROUND

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• eman mohamed fahmy

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Ahmed mohamed Ali, principle investigator

CONTACT

20+01120338983; Ahmed_mohammed@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11