Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants
NCT ID: NCT02781168
Last Updated: 2016-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
No 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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Inside the incubator;
* Clinically stable;
* No change in evoked otoacoustic emissions;
* Current weight between 1200 to 2000g.
Exclusion Criteria
* 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.
3 Days
28 Days
ALL
Yes
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Federal University of São Paulo
OTHER
Responsible Party
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Mavilde da Luz Gonçalves Pedreira
Teacher
Principal Investigators
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Mavilde LG Pedreira, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Fabricia M Araujo, RN
Role: STUDY_CHAIR
Federal University of São Paulo
Locations
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Hospital São Paulo
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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UFSP 2
Identifier Type: -
Identifier Source: org_study_id
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