Rapid Iron Infusion Study- a randomised controlled trial (RCT) of the treatment of iron deficiency anaemia in children (RIIS)
- Conditions
- Childhood Iron Deficiency AnaemiaBlood - AnaemiaDiet and Nutrition - Other diet and nutrition disorders
- Registration Number
- ACTRN12617001273370
- Lead Sponsor
- Menzies School of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 226
Aboriginal or Torres Strait Islander children with Iron deficiency anaemia (a haemoglobin level (Hb) <110g/L and mean cell volume (MCV) <75fL), will be eligible to participate in the randomised trial if the treating clinician recommends parenteral iron treatment.
1) parenteral iron treatment or blood transfusion within the last 4 weeks; 2) known iron overload, haemoglobinopathy, haemolytic anaemia, aplastic anaemia, lymphoproliferative disease or current cancer treatment; 3) febrile >38 degree centigrade or very unwell or receiving phosphate supplementation at the time of discharge; 4) lack of access to a primary health provider in the NT; 5) allergy or hypersensitivity to Ferinject or any of its excipients; 6) known serious hypersensitivity to other parenteral iron products; 7) severe asthma, eczema or allergies; 8) not planning to remain resident in the NT for 12 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Haemoglobin level [At the time of anaemia requiring additional iron treatment or at the final assessment at 6-9 months post randomisation (whichever is first). <br><br>]
- Secondary Outcome Measures
Name Time Method Clinical treatment failure[ Clinical treatment failure as defined by either anaemia requiring additional treatment or haemoglobin <110g/L at the final assessment at 6-9 months post randomisation<br>];Proportion of adverse drug reactions (urticaria, headache, nausea, vomiting etc) and serious adverse events (anaphylaxis)[ Study outcome will be gathered from remote communities within 6-9 months post randomisation];Data will be collected for the number of sick visits and well visits with reasons for attendance (primary and secondary diagnoses) in the clinic. The illnesses documented in the clinical record and any admissions to hospital will also be checked. [within 6-9 months post randomisation];Rates of attendance at the local health centre[within 6-9 months post randomisation]