Earing Protectors Influence on Newborns Preterm Sleep Pattern

Study Overview
=================
Brief Summary
-----------------
Preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the Neonatal Intermediate Care Unit (NICU) can increase morbidity and developmental deleterious effects. The aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. Prospective, randomized, controlled, crossover study conducted in NICU of two teaching hospitals from São Paulo, Brazil. The effect of earmuffs use was analyzed through polysomnography measurement during four Quiet times periods. It was also analyzed sleep related variables during 24 hours of the day. Preterm newborns characteristics and clinical characteristics were also analyzed.

Official Title
-----------------
Comparison of the Preterm Newborn Sleep With and Without the Use of Earmuffs During the Quiet Time in a Neonatal Unit

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Device: earmuffs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm Newborns inside the incubator; Preterm Newborns clinically stable; Preterm Newborns with no change in hearing screening test; Preterm Newborns current weight between 1200 and 2000g. Exclusion Criteria: Preterm Newborns in phototherapy; Preterm Newborns in use of invasive mechanical ventilation and noninvasive; Preterm Newborns with any type of congenital malformation; Preterm Newborns with periventricular hemorrhage grades II, III and IV; Preterm Newborns that received Central Nervous System depressant medication and sedative opioid analgesics in the last 24 hours; Preterm Newborns using corticoids; Preterm Newborn whose mother has a history of illicit drug use during pregnancy

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: earmuffs<br>Preterm newborns with earmuffs during the Quiet time | Device: earmuffs<br>* to compare the neonate's sleep with and without earmuffs during Quiet time at the NICU<br>|
| No Intervention: control<br>Preterm newborns without earmuffs during de Quiet time | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep period | categorized as the total time of sleep measured by polysomnography | 4 periods of Quiet time (60 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep pattern according to environmental variables | polysomnographic records and clinical environmental variables | 4 periods of Quiet time (60 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep;, Infant, Premature;, Polysomnography;, Ear Protective Devices