NCT02781168

Brief Summary

The aim of this study was to investigate the influence of the use of headphones in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction, brightness and handling NB, measure the concentrations of salivary cortisol before (baseline) and after the use of hearing protection (response) in the neonatal intensive care unit (NICU). A NICU nap periods and compare the influence of the use and non-use of hearing protection in salivary cortisol levels and sleep patterns of infants during nap periods of the NICU.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

May 9, 2016

Last Update Submit

May 19, 2016

Conditions

Premature Newborn

Keywords

Premature newbornCortisolStress

Outcome Measures

Primary Outcomes (2)

  • Comparison of Salivary Cortisol Levels and the Use of Hearing Protection

    The aim of this study was to investigate the influence of the use of earmuffs in salivary cortisol levels in newborns (NB) during periods of nap aimed at noise reduction.

    19 months

  • Sleep of premature infants and use of earmuffs

    The aim of this study was to investigate the influence of the use of earmuffs in the sleep in premature infants.

    19 months

Study Arms (2)

Use of earmuffs

EXPERIMENTAL

The earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels.

Device: use of earmuffs

No use of earmuffs

ACTIVE COMPARATOR

No use of earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels.

Device: use of earmuffs

Interventions

use of earmuffsDEVICE

The earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels. Are devices that have oval and anatomical shape that allow proper positioning of the ears of newborns. They are made with a soft foam and has hydrogel adhesive on the outer edges for attachment to the skin.

No use of earmuffsUse of earmuffs

Eligibility Criteria

Age3 Days - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Premature newborn male or female;
  • Inside the incubator;
  • Clinically stable;
  • No change in evoked otoacoustic emissions;
  • Current weight between 1200 to 2000g.

You may not qualify if:

  • In phototherapy;
  • In invasive mechanical ventilation and noninvasive;
  • With any type of congenital malformation;
  • Periventricular hemorrhage with grade II, III and IV;
  • In using any medication depressant, analgesic or corticosteroid in last 24 hours;
  • Premature newborn whose mother has a history of illicit drug use during pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Paulo

São Paulo, São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mavilde LG Pedreira, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

  • Fabricia M Araujo, RN

    Federal University of São Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 24, 2016

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)