- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03373578
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
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
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São Paulo, Brazil, 04024-002
- Federal Uiversity of São Paulo
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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
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to compare the neonate's sleep with and without earmuffs during Quiet time at the NICU
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No Intervention: control
Preterm newborns without earmuffs during de Quiet time
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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)
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categorized as the total time of sleep measured by polysomnography
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4 periods of Quiet time (60 minutes)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sleep pattern according to environmental variables
Time Frame: 4 periods of Quiet time (60 minutes)
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polysomnographic records and clinical environmental variables
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4 periods of Quiet time (60 minutes)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
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