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

Federal University of São Paulo

Status: Unknown

Conditions: Premature Newborn

Treatments: Device: use of earmuffs

Study type: Interventional

Funder types: Other

Identifiers

NCT02781168

UFSP 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 3 to 28 days old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 2 patient groups

Use of earmuffs

Experimental group

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.

Treatment:

Device: use of earmuffs

No use of earmuffs

Active Comparator group

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.

Treatment:

Device: use of earmuffs