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Earing Protectors Influence on Newborns Preterm Sleep Pattern

NCT ID: NCT03373578

Last Updated: 2017-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-02-29

Brief Summary

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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

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Conditions

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Sleep

Keywords

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sleep; Infant, Premature; Polysomnography; Ear Protective Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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earmuffs

Preterm newborns with earmuffs during the Quiet time

Group Type ACTIVE_COMPARATOR

earmuffs

Intervention Type DEVICE

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

control

Preterm newborns without earmuffs during de Quiet time

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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earmuffs

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

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Mavilde da Luz Gonçalves Pedreira

Escola Paulista de Enfermagem

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eliana M Pinheiro, phD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Mônica H Sato, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Mavilde LG Pedreira, phD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Ariane M Avelar, phD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

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Federal Uiversity of São Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Unifesp003

Identifier Type: -

Identifier Source: org_study_id