CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Evaluation of newborn stress +1 moreother
Likely dose
Not stated in record
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Search/NCT03830437
NCT03830437N/ACompleted

Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Body Weight Loss of 3±1,5% at 24 hr From Birth

Fondazione Poliambulanza Istituto Ospedaliero·observational·Posted Feb 5, 2019·Updated Jul 30, 2019

In Brief

An observational study evaluating Evaluation of newborn stress and Evaluation of body weight trend for Cortisol Overproduction. Completed, enrolled 56 participants across 1 site.

Detailed Summary

According to scientific revisions, salivary cortisol is a valid method for measuring adrenocortical activity in newborns because it is non-invasive in fact the measurement of salivary cortisol has been used as a stress marker in newborns since 1992. The mechanism by which cortisol induces stress, concerns the hypothalamic-pituitary-adrenal axis. The hypothalamus produces the corticotropin-releasing hormone, which stimulates the production of adrenocorticotropin by hypophysis. Adrenocorticotropin induces the secretion of glucocorticoids such as cortisol by stimulating the cortex of the adrenal gland. An appropriate release of cortisol due to stress factor is vital for surviving and the loss of this mechanism increase the risk of morbidity and mortality for newborns. However, prolonged exposure to a high level of cortisol may increase the risk of cognitive and behavioural disorders, hypertension, hyperlipidaemia, insulin resistance, immune deficiency and hippocampal impairment. The separation from the mother, the exposure to painful procedures but also routine interventions such as physical examination, diaper changes and bathing increase the salivary cortisol level of the newborn compared to the basal state. The measurement of salivary cortisol in the newborn therefore has the aim of understanding and preventing those stressful conditions that may have long-term side effects. For this reason, the lose weight in the first days and double weighing should be a stress practice for the newborn.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedFeb 5, 2019
Enrollment StartSep 21, 2018
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.4 years ago

Interventions

Evaluation of newborn stressother

Newborn stress will be evaluated by salivary cortisol levels at 48 hr of life. Saliva sample of the newborns will be collected in oral cavity at 48 hr of life. Samples collected will be storage at -80 C for up to 4 months and analysed by analysis laboratory of Poliambulanza Foundation.

Evaluation of body weight trendother

Body weight trend between newborns subjected to double weighing or to body weight control will be carried out at 36 hr and 48 hr of life