Earing Protectors Influence on Newborns Preterm Sleep Pattern

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03373578

Enrollment

Registered

2017-12-14

Start date

2012-10-31

Completion date

2016-02-29

Last updated

2017-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

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

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.

Interventions

DEVICEearmuffs

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Sleep period	4 periods of Quiet time (60 minutes)	categorized as the total time of sleep measured by polysomnography

Secondary

Measure	Time frame	Description
sleep pattern according to environmental variables	4 periods of Quiet time (60 minutes)	polysomnographic records and clinical environmental variables

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026