Salivary Collection in Neonates (SCiN-1 Study)
Research type
Research Study
Full title
A two-centre prospective feasibility study of a salivary collection technique in neonates
IRAS ID
346231
Contact name
Charlotte Elder
Contact email
Sponsor organisation
Sheffield Children's Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
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 - the vital stress hormone, cortisol and its inactive form, cortisone. Adrenal insufficiency (AI) describes the inability of the body to produce adequate levels of cortisol and can lead to serious illness or death. There are numerous causes, both in adults and children but a common cause of AI in premature infants is the steroid medication they are given to help mature their lungs and reduce the need for mechanical ventilation. However, we believe that AI may be over diagnosed in the neonatal population due to lack of appropriate reference data to guide doctors as to what a normal level of cortisol is in this age group.
Measurement of steroids, in particular glucocorticoids, in saliva rather than blood samples, is gaining popularity as it offers a non-invasive collection technique, reducing the need for needles and blood sampling, which is of particular advantage in children. Our research group has previously developed safe and well tolerated techniques to collect salivary samples from very young children, but salivary collection from neonates, especially premature infants being managed on a neonatal unit, presents unique challenges. This study aims to evaluate whether safe and effective salivary sampling can be undertaken in the neonatal population. Using what we learn in this study, we hope to go on in future studies to establish reference ranges for salivary glucocorticoids in order to be able to better define what is abnormal and accurately diagnose AI in the premature and neonatal population.
REC name
London - Surrey Research Ethics Committee
REC reference
24/PR/1156
Date of REC Opinion
23 Sep 2024
REC opinion
Further Information Favourable Opinion