Earing Protectors Influence on Newborns Preterm Sleep Pattern

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373578
• Other study ID #: Unifesp003
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: December 8, 2017
• Start date: October 2012
• Est. completion date: February 2016

Study information

• Verified date: August 2014
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal Uiversity of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep period	categorized as the total time of sleep measured by polysomnography	4 periods of Quiet time (60 minutes)
Secondary	sleep pattern according to environmental variables	polysomnographic records and clinical environmental variables	4 periods of Quiet time (60 minutes)