NCT03373578

Earing Protectors Influence on Newborns Preterm Sleep Pattern

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Accepted

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.

Conditions

• Sleep

Interventions

Type	Name	Description
DEVICE	earmuffs	to compare the neonate's sleep with and without earmuffs during Quiet time at the NICU

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-04-01
• Completion: 2016-02-01
• First posted: 2017-12-14
• Last updated: 2017-12-14

Locations

1 site across 1 country: Brazil