About the study

SAPSOS-2 is a prospective national multi-centre interventional study to evaluate the efficacy of oral iron supplementation in children diagnosed with preoperative iron-deficiency anaemia undergoing noncardiac surgery.

Background

Given the high incidence of preoperative anaemia in children having surgery in South Africa in the public sector and its association with poorer postoperative outcomes, it is important to assess the feasibility of a pragmatic intervention to treat preoperative anaemia in the context of a resource- constrained setting. Although intravenous iron in combination with EPO may be more effective and have fewer side effects, oral iron is relatively inexpensive and widely available in South Africa. Regular deworming may also play an important role in the treatment of preoperative anaemia and has been shown to be an effective intervention to increase baseline Hb in school age children from low- and middle- income countries.

We hypothesise that the implementation of preoperative anaemia screening and treatment of anaemic patients with a minimum of 6 weeks supplementation with oral iron will have a clinically significant effect on increasing the haemoglobin in patients with preoperative IDA.

Primary Objective

To evaluate the efficacy of oral iron supplementation in children diagnosed with preoperative IDA undergoing noncardiac surgery.

Study Design

Prospective interventional quasi-experimental pre-post study across multiple hospitals in South Africa. Patients will be screened for trial eligibility at a normal routine outpatient clinic visit. Those patients with a screening Hb meeting the criteria for anaemia according to the WHO definition30 and able to receive the oral iron for a minimum of 6 weeks prior to their planned operation, will be eligible for inclusion.

The formal laboratory blood test results will be reviewed within 48-76 hours by the research nurse to diagnose those patients who meet the pre-defined criteria for IDA. Parents & legal guardians will be contacted via telephone by the research nurse to inform them about their child’s results and to instruct them to either discontinue or continue taking the oral iron supplementation dependent on whether the results meet the pre-defined criteria for iron-deficiency anaemia.

Prior to inclusion, freely given written informed consent must be obtained from all parents or legal guardians and assent from patients where appropriate.

Participating Hospitals

Red Cross Children's Hospital

Tygerberg Hospital

Albert Luthuli Hospital

Contact information

Study Chief Investigator:

Dr Heidi Meyer

Division of Paediatric Anaesthesia,

Department of Anaesthesia & Perioperative Medicine University of Cape Town

Western Cape, South Africa E-mail: heidi.meyer@uct.ac.za Telephone: +27 (0)799988858