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NCT05681871
South African Paediatric Surgical Outcomes Study 2
Conditions: Paediatric Surgery, Anaemia, Iron Deficiency Anemia, Iron, Prospective Studies, Interventional Studies
Sex: All
Ages: 6 Months – 16 Years
Phase: PHASE2, PHASE3
Enrollment: 420
Sponsor: University of Cape Town
Summary
Preoperative anaemia has been shown to be associated with worse outcomes after surgery in both adults and children.
Limited research has been done on how common preoperative iron-deficiency anaemia (IDA) is in children and how best to treat it.
Oral iron is a relatively cost-effective treatment for IDA.
This study aims to show whether giving children with IDA oral iron for 6-12 weeks before their surgery significantly improves their haemoglobin.
Eligibility Criteria
Inclusion Criteria:Age > 6 months to <16 yearsNoncardiac surgeryElective surgeryAnaemic as per World Health Organisation criteriaExclusion Criteria:Patient or parent refusalUnable to obtain written consent at the surgical outpatient clinicSurgery planned within 6 weeks from surgical outpatient visitKnown history of acquired iron overload, family history of haemochromatosis or thalassemiaKnown reason for anaemia (e.g., untreated vitamin B12 or folate deficiency or haemoglobinopathy)Treatment with oral iron, erythropoietin, IV iron therapy or blood transfusion in the previous 12 weeksKnown hypersensitivity to oral iron or other contraindication to oral ironTemperature > 38.0 °C or receiving non-prophylactic antibioticsAcute liver failure
Source: ClinicalTrials.gov (NCT05681871). StuddyBuddy aggregates publicly available trial information.