Complications in Children With B- Thalassemia Major

NCT03462784 | Unknown

• 1 other identifier: Prev TM
• Study Type: observational
• Target: 201
• Locations: 0 countries
• Sites: N/A

Brief Summary

Worldwide, there are more than 60,000 births annually of serious forms of thalassemia .The World Health Organization considers thalassemia to be a major health burden. Beta- thalassemia is a group of recessively inherited disorders of hemoglobin synthesis characterized by reduced synthesis of the ß-globin chain caused by a mutation. The homozygous state results in severe anemia which needs regular blood transfusion.

Conditions

Beta-thalassemia

Outcome Measures

Primary Outcomes (1)

• Prevelance of Comlications of Beta -Thalassemia major in children

  Demographic data collected includ clinical diagnosis, sex, race, genotype, and phenotype. Historical data included information regarding immunizations, infection exposures, surgical procedures, organ dysfunction (Organ dysfunction was defined as a history of requiring medical treatment for heart disease, diabetes (Type 1 or 2), hypoparathyroidism, hypothyroidism, growth hormone deficiency, or gonadal failure) age at transfusion initiation, chelation therapy, type of RBC product, transfusion reactions, and antigen matching. Data will be collected from chart review, patient interviews, blood banking records, and laboratory testing. All these data will be collected to know the type of complication and measure the prevelance of these complication

  one year

Study Arms (1)

Cases

Other: Demographic, physical examination, data will becollected .

Interventions

Demographic, physical examination, data will becollected . OTHER

Demographic data collected includ clinical diagnosis, sex, race, genotype, and phenotype. Historical data included information regarding immunizations, infection exposures, surgical procedures, organ dysfunction(Organ dysfunction was defined as a history of requiring medical treatment for heart disease, diabetes (Type 1 or 2), hypoparathyroidism, hypothyroidism, growth hormone deficiency, or gonadal failure) age at transfusion initiation, chelation therapy, type of RBC product, transfusion reactions, and antigen matching. Data will be collected from chart review, patient interviews, blood banking records, and laboratory

Cases

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children who diagnosed as B thalassemia major

You may qualify if:

• All patient from 1 year up to 18 year (1year-18 year) admitted at Haematology unit at Assuit University Children Hospital who were diagnosed as Beta thalassemia major

You may not qualify if:

• Age less than 1 year( 1 ≤ year)
• Children who diagnosed as other types of thalassemia except Beta thalassemia major

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Modell B, Darlison M. Global epidemiology of haemoglobin disorders and derived service indicators. Bull World Health Organ. 2008 Jun;86(6):480-7. doi: 10.2471/blt.06.036673.

  PMID: 18568278 RESULT

• Weatherall DJ. The inherited diseases of hemoglobin are an emerging global health burden. Blood. 2010 Jun 3;115(22):4331-6. doi: 10.1182/blood-2010-01-251348. Epub 2010 Mar 16.

  PMID: 20233970 RESULT

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Demography; Restraint, Physical

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Central Study Contacts

Mohamed Hamdy Ghazaly, M.A. Ph.D.

CONTACT

01001296603; Ghazally@aun.edu.eg

Ismail Lotfy Mohamad, M.A. Ph.D.

CONTACT

01063398967; IsmailIbrahim@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 13, 2018
• Study Start: August 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01