Premature Infant DiseaseNCT06150404
A Randomized Controlled Trial to Evaluate the Effect of White Noises and Parental Voices As Protectors Against Noise Damage in a Neonatal Intensive Care Unit
A study testing White Noises and Maternal and/or Paternal voices in people with Premature Infant Disease, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial summary
The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 31 weeks and older
- Conditions the study is for
- Premature Infant Disease
- What is being tested?
- White Noises and Maternal and/or Paternal voices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to 31 Dec 2024
- 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 31 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients admitted to the NICU with gestational age at birth ≥ 31 weeks (as this is the age at which sound perception is ≥ 40 dB and there is predictable clinical stability to allow intervention delivery without excessive interruptions)
- Patients admitted to the NICU who reach gestational age ≥ 31 weeks
- Patients monitored with the following types of monitors: Masimo rainbow SET™ (Masimo); Infinity® Delta (Draeger); Infinity® Acute Care System (Draeger); Efficia CM (Philips).
Who cannot join
- Patients with gestational age at birth < 31 weeks
- Patients affected by meningitis or severe cerebral insults, congenital brain anomalies, congenital syndromes with suspected or known brain dysfunction
- Patients diagnosed with hypoxic-ischemic encephalopathy
- Patients with significant airway abnormalities resulting in altered breathing during sleep
- Patients with terminal illnesses
- Patients with congenital anomalies of the face, ears, skull, or brain
Show all 10Show fewer
- Patients with non-bacterial congenital infections
- Patients with congenital hearing deficits
- Patients whose parents or legal guardians refuse to participate in the study
- Patients already enrolled in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parents' Voice and White Noises in Neonatal Intensive Care Unit: Efficacy Evaluation Against Noises' Damage - a Randomized Controlled Trial
The goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit.
The main question it aims to answer is:
Read more
- Could the combined use of white noises and maternal and/or paternal voices reduce the negative outcomes of continuous exposure to hospital noises on newborns hospitalized in a Neonatal Intensive Care Unit?
Participants in the intervention group will listen to a recorded track composed of white noises and voices of their parents who read a story or sing a lullaby from the day of enrollment until the day of discharge, for 4 hours per day.
Researchers will compare the intervention group with the control group (who will receive the usual care provided without any intervention on the noise level) to see if babies enrolled in the intervention group show fewer events of tachycardia, tachypnea, desaturation, apnoea, and language or hearing impairment.
- Conditions
- Premature Infant Disease
- Being tested
- White Noises and Maternal and/or Paternal voices
- Keywords
- premature, nursing care, randomized controlled trial, developmental care, noises damage, Newborn intensive care unit, white noises, parental voices
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Noises and Maternal and/or Paternal voicesBehavioural
The intervention group will receive white noise and maternal and/or paternal voice for a maximum of 4 hours per day, alternated as follows: 1 hour and 30 minutes of white noise, 30 minutes of maternal and/or paternal voice, 1-hour break, 1 hour and 30 minutes of white noise, 30 minutes of maternal and/or paternal voice. The intervention is expected to start at 08:00 in the morning and conclude at 13:00 and will be delivered from the day after the enrollment - when the parents provide their voice recording - until the day of discharge.
The device for administering white noise and maternal and/or paternal voice will be placed approximately 30 cm from the head of the infant in the incubator and at the foot of the infant in the open crib.
The volume will be 45 dB for infants in incubators and infants in open cribs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Those in the intervention group will receive the administration of white noises and maternal and/or paternal voice recording. Receives: Behavioral: White Noises and Maternal and/or Paternal voices |
| Control Group | No intervention | Those enrolled in the control group will receive standard care and will be subjected to the usual level of ambient noise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of heart rate alteration
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of heart rate alteration associated with noises > 45 dB (nursing diagnosis: risk of tachycardia - HR >180 bpm - correlated with environmental exposure to noises > 45dB).
Measured: Through study completion, an average of 2 year
Reduction of oxygen saturation alteration
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of oxygen saturation alteration associated with noises > 45 dB (nursing diagnosis: risk of desaturation - SpO2 <90% - correlated with environmental exposure to noises > 45dB).
Measured: Through study completion, an average of 2 year
Reduction of respiratory rate alteration
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of respiratory rate alteration associated with noises > 45 dB (nursing diagnosis: risk of tachypnoea - RR >60 breaths per minute - correlated with environmental exposure to noises > 45dB).
Measured: Through study completion, an average of 2 year
Reduction of episodes of apnoea
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of apnoea associated with noises > 45 dB (nursing diagnosis: risk of apnoea - HR <100 bpm and SpO2 <90% - correlated with environmental exposure to noises > 45dB).
Measured: Through study completion, an average of 2 year
Secondary outcomes (2)
Reduction in Language Development Alterations
The study will assess whether there is a reduction in language development issues in the intervention group compared to the control group. This evaluation will be conducted during a follow-up assessment at 3 years of age. The nursing diagnosis being considered is "risk of impaired verbal communication related to hospitalization in the NICU."
Measured: From enrollment unitl 3 years of age
Reduction in Hearing Development Alterations
The study will also assess whether there is a reduction in hearing development issues in the intervention group compared to the control group. These evaluations will be conducted at a follow-up assessment at 3 months of age and any subsequent audiometric examinations. The nursing diagnosis being considered is "risk of compromised hearing development related to hospitalization in the NICU."
Measured: From enrollment unitl 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Feb 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: From the preliminary data analysis, some unexpected results emerged that conducted us to terminate the enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Infant DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participation in intervention or control groups will occur using simple randomization techniques. Randomization will be achieved by creating a randomization list using specialized software. The randomization algorithm will be protected. The allocation sequence will be done using sealed opaque envelopes (making it impossible to read the contents), each numbered sequentially, containing the indication of assignment to the intervention group or the control group.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Collaborators
- Eubrain
- Responsible party
- Principal investigator, Silvia Rossi, Istituto Giannina Gaslini
- Investigators
- Simona Serveli, RN, Study chair, Department of Health Profession, IRCCS Istituto Giannina Gaslini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150404
- Sponsor's protocol ID
- SR-WHTNSS1
- Status last verified
- Jan 2025
- First submitted
- 13 Nov 2023
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data could be shared under a motivated request, only anonymised and grouped in databases.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents' Voice and White Noises in Neonatal Intensive Care Unit: Efficacy Evaluation Against Noises' Damage - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06150404
- Acronym / sponsor ID
- SR-WHTNSS1
- Conditions
- Premature Infant Disease
- Keywords
- premature, nursing care, randomized controlled trial, developmental care, noises damage, Newborn intensive care unit, white noises, parental voices
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: From the preliminary data analysis, some unexpected results emerged that conducted us to terminate the enrollment.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Collaborators
- Eubrain
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 29 Nov 2023 (actual)
- 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 goal of this Randomized Controlled Trial is to test the efficacy of listening to white noises and parental voices against environmental noise damage in premature babies admitted to the Newborn Intensive Care Unit.
The main question it aims to answer is:
- Could the combined use of white noises and maternal and/or paternal voices reduce the negative outcomes of continuous exposure to hospital noises on newborns hospitalized in a Neonatal Intensive Care Unit?
Participants in the intervention group will listen to a recorded track composed of white noises and voices of their parents who read a story or sing a lullaby from the day of enrollment until the day of discharge, for 4 hours per day.
Researchers will compare the intervention group with the control group (who will receive the usual care provided without any intervention on the noise level) to see if babies enrolled in the intervention group show fewer events of tachycardia, tachypnea, desaturation, apnoea, and language or hearing impairment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participation in intervention or control groups will occur using simple randomization techniques. Randomization will be achieved by creating a randomization list using specialized software. The randomization algorithm will be protected. The allocation sequence will be done using sealed opaque envelopes (making it impossible to read the contents), each numbered sequentially, containing the indication of assignment to the intervention group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: White Noises and Maternal and/or Paternal voicesThose in the intervention group will receive the administration of white noises and maternal and/or paternal voice recording. |
| Control Group | No intervention | –Those enrolled in the control group will receive standard care and will be subjected to the usual level of ambient noise. |
Who may qualify
- Ages
- 31 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted to the NICU with gestational age at birth ≥ 31 weeks (as this is the age at which sound perception is ≥ 40 dB and there is predictable clinical stability to allow intervention delivery without excessive interruptions)
- Patients admitted to the NICU who reach gestational age ≥ 31 weeks
- Patients monitored with the following types of monitors: Masimo rainbow SET™ (Masimo); Infinity® Delta (Draeger); Infinity® Acute Care System (Draeger); Efficia CM (Philips).
Key exclusion criteria (10 listed)
- Patients with gestational age at birth < 31 weeks
- Patients affected by meningitis or severe cerebral insults, congenital brain anomalies, congenital syndromes with suspected or known brain dysfunction
- Patients diagnosed with hypoxic-ischemic encephalopathy
- Patients with significant airway abnormalities resulting in altered breathing during sleep
- Patients with terminal illnesses
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 |
|---|---|---|
| White Noises and Maternal and/or Paternal voicesThe intervention group will receive white noise and maternal and/or paternal voice for a maximum of 4 hours per day, alternated as follows: 1 hour and 30 minutes of white noise, 30 minutes of maternal and/or paternal voice, 1-hour break, 1 hour and 30 minutes of white noise, 30 minutes of maternal and/or paternal voice. The intervention is expected to start at 08:00 in the morning and conclude at 13:00 and will be delivered from the day after the enrollment - when the parents provide their voice recording - until the day of discharge. The device for administering white noise and maternal and/or paternal voice will be placed approximately 30 cm from the head of the infant in the incubator and at the foot of the infant in the open crib. The volume will be 45 dB for infants in incubators and infants in open cribs. | Behavioural | Intervention Group |
Primary outcome
Reduction of heart rate alteration
Time frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of heart rate alteration associated with noises > 45 dB (nursing diagnosis: risk of tachycardia - HR >180 bpm - correlated with environmental exposure to noises > 45dB).
Reduction of oxygen saturation alteration
Time frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of oxygen saturation alteration associated with noises > 45 dB (nursing diagnosis: risk of desaturation - SpO2 <90% - correlated with environmental exposure to noises > 45dB).
Reduction of respiratory rate alteration
Time frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of respiratory rate alteration associated with noises > 45 dB (nursing diagnosis: risk of tachypnoea - RR >60 breaths per minute - correlated with environmental exposure to noises > 45dB).
Reduction of episodes of apnoea
Time frame: Through study completion, an average of 2 year
Reduction, in the patients enrolled in the intervention group compared to the control group, in episodes of apnoea associated with noises > 45 dB (nursing diagnosis: risk of apnoea - HR <100 bpm and SpO2 <90% - correlated with environmental exposure to noises > 45dB).
2 secondary outcomes
Reduction in Language Development Alterations
Time frame: From enrollment unitl 3 years of age
Reduction in Hearing Development Alterations
Time frame: From enrollment unitl 3 months of age
Results and safety
The study was stopped early (reason given: From the preliminary data analysis, some unexpected results emerged that conducted us to terminate the enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: No. Individual participant data could be shared under a motivated request, only anonymised and grouped in databases.
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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.
Simona Serveli, RN study chair
Department of Health Profession, IRCCS Istituto Giannina Gaslini
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Noises and Maternal and/or Paternal voices in people with Premature Infant Disease, run by Istituto Giannina Gaslini at 1 site in Italy.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 21 Jan 2025. 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 Italy. 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?
The study was stopped early (reason given: From the preliminary data analysis, some unexpected results emerged that conducted us to terminate the enrollment.). 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?
Reduction of heart rate alteration (time frame: Through study completion, an average of 2 year). The study lists 4 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 21 Jan 2025.