NCT02781168

Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants

Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants: Clinical, Randomized, Controlled, Crossover

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 3 Days – 28 Days
• Healthy volunteers: Accepted

Summary

The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the neonatal intensive care unit (NICU). A NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.

Detailed description

The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU. Being the chance prosposta the use of headphones during periods of environmental control has an influence on the level of salivary cortisol and sleep in preterm infants. This is a randomized clinical trial, controlled, crossover, in which clinical intervention is introduced by the researcher that controls and varies, featuring experimental research. In this study the intervention being tested is the use of hearing protection in infants. The ear is employed in certain periods of the day. These periods established by the Neonatal Intensive Care Unit (ICU), are intended to promote environmental noise control and manipulation of the NB. Levels of cortisol present in the saliva of the newborn will be analyzed, allowing to measure the biologically active free cortisol in the body.

Conditions

• Premature Newborn

Interventions

Type	Name	Description
DEVICE	use of earmuffs	The earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels. Are devices that have oval and anatomical shape that allow proper positioning of the ears of newborns. They are made with a soft foam and has hydrogel adhesive on the outer edges for attachment to the skin.

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-05-24
• Last updated: 2016-05-24

Locations

1 site across 1 country: Brazil