Validation of cortisol measurements in neonates using the MITRA system
Research type
Research Study
Full title
Validation of cortisol measurements in very low birth weight neonates using the Mitra sampling system
IRAS ID
172046
Contact name
Anthony Emmerson
Contact email
Sponsor organisation
CMFT
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Very low birth weight premature (VLBW) infants may demonstrate signs of adrenal insufficiency and have variable cortisol levels. Levels of cortisol have been shown to very variable after birth. VLBW infants, especially those that are smaller and more premature, who are hypotensive may be unresponsive to inotropes without the addition of hydrocortisone. However high cortisol levels during the first 10 days in VLBW infants have been associated with higher morbidity and mortality.
Measurements of cortisol can be performed using saliva and blood however there are difficulties obtaining reliable saliva samples while repeated blood sampling is limited by the small circulating blood volume. VLBW infants do not show a circadian rhythm of cortisol secretion that is seen in children and adults so measurements can be taken at the same time as clinical blood sampling.
Recent development of the novel Mitra sampling system enables a consistent 10 µl of blood to be collected. This system has an advantage over dried blood spots as it is not affected by the infant’s haematocrit and would allow for repeated sampling to facilitate investigation of cortisol levels associated with different gestations, postnatal ages and intercurrent illnesses. This study will investigate the validity of this system for measurement of whole blood cortisol in VLBW infants compared with standard plasma cortisol measurements and will be supported by the Biochemistry Department at Wythenshawe Hospital where the test for cortisol is already available. Key to the project's success is the neonatal unit at St Mary's Hospital, which now supports 8,000 deliveries each year, where the PI Dr Emmerson and his research coordinator work. Professor Keevil provides expertise in Clinical Biochemistry and will advise on the design and facilitate the analysis of the samples and Dr Roberts from the department of statistics will help with the analysis of the study.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0078
Date of REC Opinion
9 Feb 2015
REC opinion
Favourable Opinion