Overview

This trial is active, not recruiting.

Condition premature newborn
Treatment use of earmuffs
Sponsor Federal University of São Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date June 2013
End date June 2016
Trial size 12 participants
Trial identifier NCT02781168, UFSP 2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
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.
(Active Comparator)
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
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.

Primary Outcomes

Measure
Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
time frame: 19 months
Sleep of premature infants and use of earmuffs
time frame: 19 months

Eligibility Criteria

Male or female participants up to 28 days old.

Inclusion Criteria: - Premature newborn male or female; - Inside the incubator; - Clinically stable; - No change in evoked otoacoustic emissions; - Current weight between 1200 to 2000g. Exclusion Criteria: - 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.

Additional Information

Official title Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants: Clinical, Randomized, Controlled, Crossover
Principal investigator Mavilde LG Pedreira, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.