Clinical trial NCT02781168: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Newborn
Keywords: Premature newborn
Cortisol
Stress
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
timeFrame: 19 months
measure: Sleep of premature infants and use of earmuffs
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Mavilde LG Pedreira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Fabricia M Araujo, RN
role: STUDY_CHAIR
References: