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Salivary Cortisol as Stress Marker in Newborns Subjected to Double Weighing With Physiological Body Weight

NCT03830437 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 56

Last updated 2019-07-30

No results posted yet for this study

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.

Conditions

  • Cortisol Overproduction

Interventions

OTHER

Evaluation of newborn stress

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.

OTHER

Evaluation of body weight trend

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

Sponsors & Collaborators

  • Fondazione Poliambulanza Istituto Ospedaliero

    lead OTHER

Principal Investigators

  • Giuseppe De Bernardo, M.D. · Fondazione Poliambulanza Istituto Ospedaliero

  • Laura Linetti, Dott. · Fondazione Poliambulanza Istituto Ospedaliero

Eligibility

Min Age
37 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2019-06-01
Completion
2019-06-01

Countries

  • Italy

Study Locations

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Read the full study record

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View NCT03830437 on ClinicalTrials.gov