Earing Protectors Influence on Newborns Preterm Sleep Pattern

December 8, 2017 updated by: Mavilde da Luz Gonçalves Pedreira, Federal University of São Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 04024-002
        • Federal Uiversity of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep period
Time Frame: 4 periods of Quiet time (60 minutes)
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
Time Frame: 4 periods of Quiet time (60 minutes)
polysomnographic records and clinical environmental variables
4 periods of Quiet time (60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Eliana M Pinheiro, phD, Federal University of São Paulo
  • Principal Investigator: Mônica H Sato, MSc, Federal University of São Paulo
  • Study Director: Mavilde LG Pedreira, phD, Federal University of São Paulo
  • Study Chair: Ariane M Avelar, phD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

December 8, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

August 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • Unifesp003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep

Clinical Trials on earmuffs

3
Subscribe