Sheffield Children's Hospital projects

A prospective feasibility study of a salivary collection method for the measurement of salivary glucocorticoids in neonates

Can we use salivary glucocorticoids to better understand adrenal function in neonates?

Learn more about this project

Supervisors

Dr Charlotte Elder (c.j.elder@sheffield.ac.uk)

Dr Joseph Tonge (joseph.tonge@sheffield.ac.uk)

Abstract and methodology

The adrenal glands produce a number of different steroid hormones; those involved in metabolism (glucocorticoids, principally cortisol and its more inactive form, cortisone), salt and water balance (aldosterone) and sex steroids (oestrogen and testosterone). Inadequate cortisol production, adrenal insufficiency, is challenging to diagnose and is associated with considerable morbidity and mortality. 

The use of salivary samples to screen and diagnose disease is growing in popularity. The non-invasive nature of salivary collection, negating the need for blood tests and needles, makes it a particularly attractive medium for use in children. Dr Elder’s research group has been developing non-invasive screening and diagnostic tests for adrenal insufficiency using salivary samples. To tackle the significant obstacles to salivary collection in young children we have previously developed and validated salivary collection techniques for use in pre-school age children and infants. We would like to extend this work to the neonatal population, especially premature infants. Validating a salivary collection technique in neonates would then facilitate salivary glucocorticoid sampling to study adrenal function in neonates, to better define abnormal.

Aims

• To evaluate whether the SalivaBio is a suitable salivary collection device for the use in neonates of different gestational ages (SCiN-1a study)
• To evaluate parents’ and healthcare professionals’ opinions on the utility, tolerability and acceptability of salivary collection in the in-patient neonatal population (SCiN-1b study)
• To describe the relationship between serum cortisol and salivary cortisol / cortisone in the premature and term neonatal population (SCiN-2 study)

Methods

A multi-centre clinical study on neonatal ICUs (NICU) investigating a new way to measure adrenal function in this age group. The collection of salivary samples from neonates will follow a standardised protocol. It is anticipated the studies will be run across three NICU sites: Sheffield, Nottingham and GOSH, London. The student will be primarily based in Sheffield but would have the opportunity to attend other sites to assist with study recruitment, and to train staff to use the collection technique. They will also be required to collect survey data from healthcare providers on their thoughts on the salivary collection technique. 

• SCiN-1a study: To determine whether the SalivaBio can be used to collect 0.5mL saliva (required volume for analysis of salivary steroids) in 80% of participants we will be evaluating salivary collection in a variety of patients – across different gestational ages and including those receiving ventilatory support. The amount of saliva collected, time taken and contamination rates will all be studied.
• SCiN-1b study: Two questionnaire studies evaluating the ease, tolerability and acceptability of salivary collection, one in parents and one in NICU healthcare professionals.
• SCiN-2 study: Analysis of paired samples to describe the relationship of serum cortisol and the salivary glucocorticoids (cortisol & cortisone) by gestational age and weight.

Outcomes

By the end of the intercalation project, the expectation is the student will have worked with their supervisors and sites to complete the studies and analyse the results. Being the first studies of their kind, we anticipate the work may lead to presentations, at both national and international conferences, and a publication (no guarantees as this is dependent on successful completion of the studies and the results).

Type of project

Clinical or Surgical project - based in the clinical environment with patients/including service evaluation

Additional training or teaching

Dr Elder is an experienced supervisor, and the student will benefit from support and training from the wider research group. Dr Tonge will co-supervise the project and has worked on validation of salivary collection techniques in young children and the pilot study for SCiN. The student will get experience in literature reviewing with critical appraisal, clinical studies, following protocols, questionnaire surveys, collecting data, analysing data and presenting results. 

Working patterns may be reasonably flexible but occasionally meetings with project supervisor/day-to-day supervisor may be outside of normal office hours due to nature of clinical work. Should attendance be required at neonatal units outside of Sheffield, travel expenses will be reimbursed.

The student, if they wish and time permits, may attend some paediatric endocrinology clinics at Sheffield Children’s Hospital to develop a greater understanding of how adrenal insufficiency is managed. 

Ethics requirements

Original research involving human tissues/human participants and/or patient details and information: UREC or NHS REC ethics approval needed.