Earing Protectors Influence on Newborns Preterm Sleep Pattern

NCT03373578 | Completed DMC

• 1 other identifier: Unifesp003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleep;; Infant, Premature;; Polysomnography;; Ear Protective Devices

Outcome Measures

Primary Outcomes (1)

• Sleep period

  categorized as the total time of sleep measured by polysomnography

  4 periods of Quiet time (60 minutes)

Secondary Outcomes (1)

• sleep pattern according to environmental variables

  4 periods of Quiet time (60 minutes)

Study Arms (2)

earmuffs

ACTIVE COMPARATOR

Preterm newborns with earmuffs during the Quiet time

Device: earmuffs

control

NO INTERVENTION

Preterm newborns without earmuffs during de Quiet time

Interventions

earmuffs DEVICE

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

earmuffs

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Federal Uiversity of São Paulo

São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Eliana M Pinheiro, phD

  Federal University of São Paulo

  STUDY DIRECTOR

• Mônica H Sato, MSc

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Mavilde LG Pedreira, phD

  Federal University of São Paulo

  STUDY DIRECTOR

• Ariane M Avelar, phD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Escola Paulista de Enfermagem

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: December 14, 2017
• Study Start: October 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: February 1, 2016
• Last Updated: December 14, 2017

Record last verified: 2014-08

Locations

BR (1)