Inter-current illness, teething or immunisations and blood phe.
Research type
Research Study
Full title
The relationship between inter-current illness, teething or routine immunisations and blood phenylalanine concentration in children with phenylketonuria; a feasibility study.
IRAS ID
235094
Contact name
Katherine Curtis-Tyler
Contact email
Sponsor organisation
City University London
Duration of Study in the UK
0 years, 8 months, 23 days
Research summary
Phenylketonuria (PKU) is an inherited metabolic disorder resulting in elevated levels of phenylalanine (an amino acid found in dietary protein) in the blood which is toxic to the brain. Treatment is a protein-restricted diet which must be introduced within the first few days of life. The diet needs to be well managed during the critical period for structural brain development; 0 - 12 years of age. Fluctuations in blood phenylalanine concentration as well as raised phenylalanine levels are associated with reduced cognitive outcome. New European PKU management guidelines have been published which require tighter control of blood phenylalanine compared to previous UK guidelines. Healthcare professionals are challenged to review management and the factors which impact blood phenylalanine control.
Minor illnesses (referred to as inter-current illnesses) are recognised to be associated with a rise in blood phenylalanine concentration. Teething and routine immunisations may have a similar association. To date, in Europe, general consensus is that as inter-current illnesses are of short duration their impact on neurological development is inconsequential.
There is a paucity of research looking at how illness impacts and the frequency it impacts on blood phenylalanine concentrations in childhood.
This study has been designed to assess the feasibility of exploring the relationship between inter-current illness, teething or routine immunisations and blood phenylalanine concentrations/ fluctuations in children with PKU aged 0 - 12 years. Data on episodes of inter-current illness, teething and following routine immunisations will be collected prospectively over 3-6 months using a 'Symptom Log'. Concurrent blood phenylalanine concentrations collected during episodes will be compared to concentrations when well. Parental experience of study participation and opinions on study design will be collected.
The results of this preliminary study will guide the planning of a large-scale, multi-centre study that seeks to add to current understanding in the management of PKU.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0472
Date of REC Opinion
7 Dec 2017
REC opinion
Favourable Opinion