Earing Protectors Influence on Newborns Preterm Sleep Pattern

Not Applicable

Completed

• Conditions: Sleep
• Interventions: Device: earmuffs

• Registration Number: NCT03373578
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Status Verified: 2014-08
• Study First Submitted: 2014-08-07
• Primary Completion: 2015-04
• Study Completion: 2016-02
• Study First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
earmuffs	earmuffs	Preterm newborns with earmuffs during the Quiet time

Primary Outcome Measures

Name	Time	Method
Sleep period	4 periods of Quiet time (60 minutes)	categorized as the total time of sleep measured by polysomnography

Secondary Outcome Measures

Name	Time	Method
sleep pattern according to environmental variables	4 periods of Quiet time (60 minutes)	polysomnographic records and clinical environmental variables

Trial Locations

Locations (1)

Federal Uiversity of São Paulo; 🇧🇷 São Paulo, Brazil