PrematureNCT04565210
Effects of Oriental Music on Preterm Infants
A study testing Music exposure and Silence in people with Premature and Behavior, Child, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU. Read more about this study
- Who is it for?
- Ages 14 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Premature, Behavior, Child
- What is being tested?
- Music exposure and Silence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Oct 2020to 30 Jan 2025
- 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 14 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
- Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.
Who cannot join
- Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
- Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.
Read the detailed description
Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.
We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.
- Conditions
- Premature, Behavior, Child
- Being tested
- Music exposure, Silence
- Keywords
- Music therapy, Premature infant, Heart rate variability, Behavior state
- Medical subject headings
- Premature Birth, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music exposureOther
Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
SilenceOther
Also called No music
Participants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
| Study group | Role | What they receive |
|---|---|---|
| Oriental music | Experimental | Infants assigned to this group will be exposed to oriental music. Receives: Other: Music exposure |
| Western music | Active comparator | Infants assigned to this group will be exposed to western music. Receives: Other: Music exposure |
| Silence / control | Placebo comparator | Infants assigned to this group will be exposed to the same protocol but using a track of silence. Receives: Other: Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).
Measured: 3 years
Secondary outcomes (3)
Mean Respiratory rate
The respiratory rate will be retrieved from bedside monitors.
Measured: 3 years
Oxygen Saturation
The oxygen saturation will be retrieved from bedside monitors.
Measured: 3 years
Behavioral state
The behavioral score will be assessed using a 7- point score by a certified nurse.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start15 Oct 2020
- Primary completion15 Feb 2023
- Study completion30 Jan 2025
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lama Charafeddine, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565210
- Sponsor's protocol ID
- SBS-2020-0284
- Status last verified
- Oct 2024
- First submitted
- 7 Sep 2020
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oriental Music oN Preterm InfAnts: A Randomized Controlled Trial. (OMNIA Trial)
- ClinicalTrials.gov ID
- NCT04565210
- Acronym / sponsor ID
- SBS-2020-0284
- Conditions
- Premature, Behavior, Child
- Keywords
- Music therapy, Premature infant, Heart rate variability, Behavior state
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 102 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 25 Sep 2020 (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 study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.
Detailed description
Music exposure during care of preterm infants is the subject of increasing research. Many studies have shown positive impact of music exposure such as classical western music, lullabies or Quran on pain and physiological parameters of preterm infants in a neonatal intensive care unit (NICU) setting. No such study have explored the effect of oriental music which is the main popular music listened to in the Levant and Middle East and North Afrika (MENA) region.
We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oriental music | Experimental | Other: Music exposureInfants assigned to this group will be exposed to oriental music. |
| Western music | Active comparator | Other: Music exposureInfants assigned to this group will be exposed to western music. |
| Silence / control | Placebo comparator | Other: SilenceInfants assigned to this group will be exposed to the same protocol but using a track of silence. |
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Clinically stable infants born between 28 and 366/7 weeks of gestation and ≥31 weeks Post Menstrual Age (PMA).
- Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.
Key exclusion criteria (2 listed)
- Congenital anomaly affecting heart rate and hearing, significant brain insult (such as severe or moderate hypoxic ischemic encephalopathy, intraventricular hemorrhage (IVH) grade 3 or 4 or periventricular leukomalacia) that might affect the neurodevelopmental outcome.
- Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.
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 |
|---|---|---|
| Music exposureParticipants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone. | Other | Oriental music, Western music |
| SilenceAlso: No musicParticipants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone. | Other | Silence / control |
Primary outcome
Heart rate variability
Time frame: 3 years
It consists of changes in the time intervals between consecutive heartbeats called inter-beat intervals (RR).
3 secondary outcomes
Mean Respiratory rate
Time frame: 3 years
Oxygen Saturation
Time frame: 3 years
Behavioral state
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.
Lama Charafeddine, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music exposure and Silence in people with Premature and Behavior, Child, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 2 inclusion and 2 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 4 Apr 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 Lebanon. 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. Some participants in this study may receive a placebo. 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: Lack of recruitment). 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?
Heart rate variability (time frame: 3 years). 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 4 Apr 2025.