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Completed

NCT Number: NCT03373578

Earing Protectors Influence on Newborns Preterm Sleep Pattern

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.

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Key information

Conditions

Sleep Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal Uiversity of São Paulo

São Paulo, 04024-002, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

earmuffs

Device

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

Primary outcomes

  1. Sleep period

    Time frame: 4 periods of Quiet time (60 minutes)

    categorized as the total time of sleep measured by polysomnography

Secondary outcomes

  1. sleep pattern according to environmental variables

    Time frame: 4 periods of Quiet time (60 minutes)

    polysomnographic records and clinical environmental variables

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Dec 14, 2017
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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