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

Premature Newborn Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02781168
• Other study ID #: UFSP 2
• Status: Active, not recruiting
• Phase: N/A
• First received: May 9, 2016
• Last updated: May 19, 2016
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth
• Premature Newborn

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	19 months	Yes
Primary	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.	19 months	Yes