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

Primary Purpose

Premature Newborn

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
use of earmuffs
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Newborn focused on measuring Premature newborn, Cortisol, Stress

Eligibility Criteria

3 Days - 28 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Use of earmuffs

No use of earmuffs

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
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
The aim of this study was to investigate the influence of the use of earmuffs in the sleep in premature infants.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2016
Last Updated
May 19, 2016
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02781168
Brief Title
Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Newborn
Keywords
Premature newborn, Cortisol, Stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of earmuffs
Arm Type
Experimental
Arm Description
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.
Arm Title
No use of earmuffs
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
use of earmuffs
Intervention Description
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 Outcome Measure Information:
Title
Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
Description
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.
Time Frame
19 months
Title
Sleep of premature infants and use of earmuffs
Description
The aim of this study was to investigate the influence of the use of earmuffs in the sleep in premature infants.
Time Frame
19 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mavilde LG Pedreira, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabricia M Araujo, RN
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital São Paulo
City
São Paulo
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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

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