Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants
- Conditions
- Premature Newborn
- Interventions
- Device: use of earmuffs
- Registration Number
- NCT02781168
- Lead Sponsor
- Federal University of São Paulo
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- Premature newborn male or female;
- Inside the incubator;
- Clinically stable;
- No change in evoked otoacoustic emissions;
- Current weight between 1200 to 2000g.
- In phototherapy;
- In invasive mechanical ventilation and noninvasive;
- With any type of congenital malformation;
- Periventricular hemorrhage with grade II, III and IV;
- In using any medication depressant, analgesic or corticosteroid in last 24 hours;
- Premature newborn whose mother has a history of illicit drug use during pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description No use of earmuffs use of earmuffs No use of 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. Use of earmuffs 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.
- Primary Outcome Measures
Name Time Method Comparison of Salivary Cortisol Levels and the Use of Hearing Protection 19 months The aim of this study was to investigate the influence of the use of earmuffs in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction.
Sleep of premature infants and use of earmuffs 19 months The aim of this study was to investigate the influence of the use of earmuffs in the sleep in premature infants.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital São Paulo
🇧🇷São Paulo, Brazil