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Earing Protectors Influence on Newborns Preterm Sleep Pattern

NCT03373578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-12-14

No results posted yet for this study

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

DEVICE

earmuffs

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Eliana M Pinheiro, phD · Federal University of São Paulo

  • Mônica H Sato, MSc · Federal University of São Paulo

  • Mavilde LG Pedreira, phD · Federal University of São Paulo

  • Ariane M Avelar, phD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2015-04-30
Completion
2016-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03373578 on ClinicalTrials.gov