Premature NewbornNCT02781168
Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants
A study testing use of earmuffs in people with Premature Newborn, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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)… Read more about this study
- Who is it for?
- Ages 3 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Premature Newborn
- What is being tested?
- use of earmuffs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Premature newborn male or female;
- Inside the incubator;
- Clinically stable;
- No change in evoked otoacoustic emissions;
- Current weight between 1200 to 2000g.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants: Clinical, Randomized, Controlled, Crossover
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.
Read the detailed description
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 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. Being the chance prosposta the use of headphones during periods of environmental control has an influence on the level of salivary cortisol and sleep in preterm infants.
This is a randomized clinical trial, controlled, crossover, in which clinical intervention is introduced by the researcher that controls and varies, featuring experimental research.
In this study the intervention being tested is the use of hearing protection in infants. The ear is employed in certain periods of the day. These periods established by the Neonatal Intensive Care Unit (ICU), are intended to promote environmental noise control and manipulation of the NB.
Levels of cortisol present in the saliva of the newborn will be analyzed, allowing to measure the biologically active free cortisol in the body.
- Conditions
- Premature Newborn
- Being tested
- use of earmuffs
- Keywords
- Premature newborn, Cortisol, Stress
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: use of earmuffs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Mavilde da Luz Gonçalves Pedreira, Federal University of São Paulo
- Investigators
- Mavilde LG Pedreira, PhD, Principal investigator, Federal University of São PauloFabricia M Araujo, RN, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781168
- Sponsor's protocol ID
- UFSP 2
- Status last verified
- May 2016
- First submitted
- 9 May 2016
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Use of Hearing Protection in the Salivary Cortisol Level and in the Sleep of Premature Infants: Clinical, Randomized, Controlled, Crossover
- ClinicalTrials.gov ID
- NCT02781168
- Acronym / sponsor ID
- UFSP 2
- Conditions
- Premature Newborn
- Keywords
- Premature newborn, Cortisol, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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. Being the chance prosposta the use of headphones during periods of environmental control has an influence on the level of salivary cortisol and sleep in preterm infants.
This is a randomized clinical trial, controlled, crossover, in which clinical intervention is introduced by the researcher that controls and varies, featuring experimental research.
In this study the intervention being tested is the use of hearing protection in infants. The ear is employed in certain periods of the day. These periods established by the Neonatal Intensive Care Unit (ICU), are intended to promote environmental noise control and manipulation of the NB.
Levels of cortisol present in the saliva of the newborn will be analyzed, allowing to measure the biologically active free cortisol in the body.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of earmuffs | Experimental | Device: use of earmuffsThe 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. |
| No use of earmuffs | Active comparator | Device: use of earmuffsNo 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. |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature newborn male or female;
- Inside the incubator;
- Clinically stable;
- No change in evoked otoacoustic emissions;
- Current weight between 1200 to 2000g.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of earmuffsThe 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. | Device | No use of earmuffs, Use of earmuffs |
Primary outcome
Comparison of Salivary Cortisol Levels and the Use of Hearing Protection
Time frame: 19 months
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.
Sleep of premature infants and use of earmuffs
Time frame: 19 months
The aim of this study was to investigate the influence of the use of earmuffs in the sleep in premature infants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mavilde LG Pedreira, PhD principal investigator
Federal University of São Paulo
Fabricia M Araujo, RN study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of earmuffs in people with Premature Newborn, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Salivary Cortisol Levels and the Use of Hearing Protection (time frame: 19 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.