Neonatal, Infant & Toddler Salivary Study (NITS Study)
Research type
Research Study
Full title
A prospective feasibility study of a novel salivary collection technique for the measurement of salivary cortisol and cortisone in neonates, infants and toddlers.
IRAS ID
295437
Contact name
Charlotte Elder
Contact email
Sponsor organisation
Sheffield Children's NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 18 days
Research summary
Summary of Research
The adrenal glands sit above the kidneys and are part of the body's endocrine system. They produce a number of different steroid hormones including glucocorticoids, principally the stress hormone, cortisol and its more inactive form, cortisone. Adrenal insufficiency (AI) describes the inability of the body to produce adequate levels of this vital stress hormone. It is associated with considerable mortality and morbidity. There are numerous causes, both in adults and children. The commonest cause in children is AI secondary to steroid medication prescribed for inflammatory conditions such as arthritis and asthma. AI is usually permanent but, especially in those patients taking steroid medication, it may not be, and repeated testing may be required. Testing for AI requires measurement of cortisol. Cortisol levels change during the day (highest soon after waking) and increase in response to stress. There is a lack of data on what constitutes a normal cortisol level under different conditions in children, especially babies and very young children. We would like to use salivary glucocorticoid sampling to study normal responses in children, in order to be able to better define what is abnormal, to ensure appropriate and safe management of children at risk of AI in the future. The current salivary collection techniques (SCT) require active patient participation, present a potential choking hazard, and are therefore unsuitable for very young children. We have been working on a SCT suitable for neonates, infants and toddlers. Our novel SCT uses a salivary steroid swab encased in a pacifier/dummy (SaliPac) and will enable study of normal adrenal gland function at different ages and under different conditions and disease states from which we will construct normal reference ranges. The final step in the validation of the novel SCT is this patient study where usability, patient tolerability and carer acceptability will be examined.
Summary of Results
We recruited 30 participants aged 5 years or under to compare two salivary collection devices in a single site study. We calculated the mean time taken to collect 1mL using the salivary collection device, and evaluated whether this was different between the collection devices. We found no significant difference in the time taken to collect 1mL of saliva. Both collection devices collected sufficient saliva which could be analysed for salivary steroid levels. Although we did not measure the steroids in this study, it highlighted the ability of both devices to collect enough saliva should it be needed. We also found a high level of acceptability from parents/carers as well as the children using the device. We therefore met our objectives set out to evaluate the two collection devices and their ability to collect saliva from young children.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0105
Date of REC Opinion
18 May 2021
REC opinion
Further Information Favourable Opinion