CompletedPhase 4

South African Paediatric Surgical Outcomes Study 2

South Africa755 participantsStarted 2023-02-09

Plain-language 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.

Who can participate

Age range6 Months – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 6 months to \<16 years * Noncardiac surgery * Elective surgery * Anaemic as per World Health Organisation criteria Exclusion Criteria: * Patient or parent refusal * Unable to obtain written consent at the surgical outpatient clinic * Surgery planned within 4 weeks from surgical outpatient visit * Known history of acquired iron overload, family history of haemochromatosis or thalassemia * Known 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 weeks * Known hypersensitivity to oral iron or other contraindication to oral iron * Temperature \> 38.0 °C or receiving non-prophylactic antibiotics * Acute liver failure

What they're measuring

Delta Haemoglobin = Change in haemoglobin pre- and post- oral iron supplementation

Timeframe: 4-12 weeks

Trial details

NCT IDNCT05681871

SponsorUniversity of Cape Town

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

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