RecruitingPhase 3Phase 4ACTRN12617001273370

Rapid Iron Infusion Study- a randomised controlled trial (RCT) of the treatment of iron deficiency anaemia in children (RIIS)

Rapid ferric carboxymaltose infusion (Ferinject) for Iron Deficiency Anaemia in Aboriginal children: a randomised controlled trial


Sponsor

Menzies School of Health Research

Enrollment

226 participants

Start Date

Sep 13, 2017

Study Type

Interventional

Conditions

Summary

The Rapid Iron Infusion Study (RIIS) is a randomised controlled trial for Aboriginal children with severe iron deficiency anaemia, The aim is to assess whether a single intravenous infusion of ferric carboxymaltose (Ferinject) given over 15 minutes in children prior to their discharge from hospital compared to the standard treatment with intramuscular iron injections as per CARPA Manual, will improve haemoglobin levels and reduce the risk of further anaemia. The potential benefits of rapid iron infusions include higher haemoglobin levels, fewer painful intramuscular injections, better adherence to recommended treatment, and less use of primary health care resources.


Eligibility

Sex: Both males and femalesMax Age: 6 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a single intravenous (IV) iron infusion given over 15 minutes can treat iron deficiency anaemia better than the current standard treatment of intramuscular (IM) iron injections in young Aboriginal and Torres Strait Islander children. Iron deficiency anaemia in early childhood affects brain development and immunity. IV infusion with a drug called ferric carboxymaltose (Ferinject) may boost haemoglobin levels faster, reduce the number of painful injections, and improve adherence to treatment compared with repeated IM injections. You may be eligible if: - Your child is Aboriginal or Torres Strait Islander - Your child has iron deficiency anaemia (haemoglobin below 110 g/L and low mean cell volume below 75 fL) - Your child's treating clinician has recommended parenteral (injectable) iron treatment - Your child is 6 years of age or younger You may NOT be eligible if: - Your child has received injectable iron or a blood transfusion in the past 4 weeks - Your child has a known blood disorder (e.g., thalassaemia) or iron overload - Your child has a fever above 38°C or is very unwell at discharge - Your child has a known allergy to Ferinject or similar iron products - Your child has severe asthma or allergies - Your child will not remain in the Northern Territory for 12 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Single Ferric carboxymaltose infusion (Ferinject) 20mg/kg over 15 minutes in normal saline solution administered prior to discharge from hospital

Single Ferric carboxymaltose infusion (Ferinject) 20mg/kg over 15 minutes in normal saline solution administered prior to discharge from hospital


Locations(2)

Royal Darwin Hospital - Tiwi

NT, Australia

Katherine Hospital - Katherine

NT, Australia

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ACTRN12617001273370