PALE study
Research type
Research Study
Full title
Non-invasive assessment of anaemia in children attending community paediatric clinics: A feasibility study
IRAS ID
265078
Contact name
Richard Lee-Kelland
Contact email
Sponsor organisation
2019_020
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Iron deficiency anaemia is the most common mineral deficiency with a worldwide prevalence of around 20-30%, perhaps as high as 40-60% in developing countries (WHO 2017). In the UK the prevalence has not been well established, particularly for older children. A figure of 28% with iron deficiency leading to 12% with anaemia (Booth 1997) has been given.
A lack of iron in the diet causes anaemia by impairing the production of haemoglobin which is needed to bind oxygen in the blood. Symptoms of iron deficiency anaemia include tiredness, confusion and irritability. In children, there are long standing concerns that iron deficiency may lead to impaired development. Numerous observational studies have identified a link between developmental difficulties and iron deficiency anaemia (Lozoff 2006). In addition, difficulties with sleep (Patrico 2010) and behavioural difficulties (Corapci 2006, Lozhoff 2012) have been reported. There is growing acceptance that iron deficiency anaemia is a major public health concern, particularly in socially deprived areas. The condition is easily treatable through dietary supplementation with iron.
Screening children for iron deficiency has been previously suggested and reviewed by the UK national screening program (Bazian 2012) but screening has been hampered by the need for a blood test to confirm anaemia.
However, it is now possible to test for anaemia non-invasively by using transcutaneous haemoglobin monitors, which can identify anaemia by simply placing a probe over the skin. The test is quick (30 seconds), painless and has similar sensitivity/specificity to blood draw (Raikhel 2012).
The aim of this study is to assess the feasibility of a study of measuring anaemia via a non-invasive device in clinic. Outcomes will assess the ability to successfully recruit children from clinic, test for anaemia and complete symptom questionnaires in clinic. The results would inform a larger open label trial assessing if screening/treatment of anaemia can improve functional symptoms in children with neurodisability presenting to community paediatrics services.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
19/WM/0333
Date of REC Opinion
15 Nov 2019
REC opinion
Further Information Favourable Opinion