Premature Brain OxygenationNCT02471482
Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants
A study testing Mozart music lullaby in people with Premature Brain Oxygenation, run by Coombe Women and Infants University Hospital.
Trial summary
This study is intended to see the effect of Mozart music on oxygen content of brain of premature infants once they achieve corrected gestation of 28-32 weeks and are clinically stable. Each baby is its own control. Difference of Oxygenation of brain will be measured during period with and without music. Read more about this study
- Who is it for?
- Ages 7 to 35 days
- Conditions the study is for
- Premature Brain Oxygenation
- What is being tested?
- Mozart music lullaby
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jul 2015
- 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 7 to 35 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Babies with corrected age of 28-32(28+0 to32+0) weeks of gestation, more than seven days old
- Breathing spontaneously in room air or stable on nCPAP with FiO2 requirement less than 30%
- Not requiring inotropic support
- On full enteral feeds.
Who cannot join
- Babies with major congenital abnormalities
- Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on cranial ultrasound
About this study
Official title: Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants Between 28-32 Weeks of Corrected Gestation
This study is intended to see the effect of Mozart music on oxygen content of brain of premature infants once they achieve corrected gestation of 28-32 weeks and are clinically stable. Each baby is its own control. Difference of Oxygenation of brain will be measured during period with and without music. In addition behavioural response of baby will be recorded during intervention
Read the detailed description
Study Group:
Stable Infants of corrected age of 28-32weeks will be enrolled at more than seven days age according to inclusion criteria.
An informed written consent will be obtained from parents/guardians after providing information leaflet and verbal explanation.
INCLUSION CRITERIA:
- Babies with corrected age of 28-32(28+0 to32+0) weeks of gestation, more than seven days old
- Breathing spontaneously in room air or stable on nCPAP with FiO2 requirement less than 30%
- Not requiring inotropic support
- On full enteral feeds.
EXCLUSION CRITERIA:
- Babies with major congenital abnormalities
- Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on cranial ultrasound
Study Design:
A randomized crossover study will be conducted in tertiary care level at Coombe Women and Infants University Hospital, Dublin.
As this is a randomized crossover study, each baby will act as his/her own control. Enrolled babies will be randomized to 'Music' or 'No Music'. All babies will be studied one hour after feed. The baby randomized to 'Music' will be played music for 30 minutes with recording of cerebral oxygenation (by using Near infrared spectroscopy) and vital signs (respiratory rate, heart rate, oxygen saturations and frequency of apneic episodes every 10 minutes) followed by 10 minutes of "washout" period and then period of no music for next 30 minutes (with same variables recorded as outlined for music session).
Baby randomized to 'No Music' will have no music in first 30 minutes of study followed by 10 minutes of "washout" period and then 30 minutes of music. This cycle will be repeated every 6 hours for 24 hours.
In addition the investigators will observe the behavioral response of baby during the study period by video recording which will be 'Mute' video recorded and then reviewed by our developmental staff. The behavior will be documented on 'Neonatal Behavioral Observation Sheet'. The observations will include, in addition to vital signs, the facial expression, posture and motor responses of baby during phases of music and no music.
The investigators plan to blind the study to the medical staff and also to the researchers at the time of the study (using research blind mode on near infrared spectroscopy machine). In this mode the data are stored, however not displayed at the time of the study.
Recorded Mozart Lullaby will be played. The noise level will be kept below 45db as recommended by American Academy of Pediatrics and will be monitored by sound monitor placed in incubator during the study period. Enrolled babies will have hearing screening performed prior to discharge from hospital.
Randomization: Sealed opaque envelopes
Music:
The music used will be Mozart Lullaby. This will be played on a small MP3 that will be placed baby's incubator 5cm away from baby's head. The noise level is aimed to be kept under 45dB as per hospital recommendation by adjusting volume of MP3 player. TheMP3 player will be covered in a clean plastic bag for hygiene purpose. The background will be kept to minimum during the study period.
Statistical analysis:
Statistical analysis will be performed using the SPSS software, V.17. Data will be analyzed by t-test to determine significant difference of cerebral blood flow during phase with and without music. Significance will be defined as p<0.05. As there are no data for normal brain oxygenation for the cohort studied, the investigators plan to enroll 30 infants in the pilot phase.
- Conditions
- Premature Brain Oxygenation
- Being tested
- Mozart music lullaby
- Keywords
- Near Infra Red Spectrometry, Cerebral oxygenation, Mozart music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mozart music lullabyOther
Also called Music
Recorded Mozart Lullaby will be played. The noise level will be kept below 45db as recommended by American Academy of Pediatrics and will be monitored by sound monitor placed in incubator during the study period. Enrolled babies will have hearing screening performed prior to discharge from hospital.
| Study group | Role | What they receive |
|---|---|---|
| Music First group | Experimental | Mozart music lullaby for 30 minutes with recording of cerebral oxygenation (by using Near infrared spectroscopy) and vital signs (respiratory rate, heart rate, oxygen saturations and frequency of apneic episodes continuously) followed by 10 minutes of "washout" period and then period of no music for next 30 minutes (with same variables recorded as outlined for music session).
This cycle is repeated every 6 hours for 24 hours. In addition, the behavioral response of baby is observed during the study period by video recording which will be in 'Mute' video mode and then reviewed by our developmental staff Receives: Other: Mozart music lullaby |
| No Music First group | Experimental | No music in first 30 minutes of study followed by 10 minutes of "washout" period and then 30 minutes of Mozart music lullaby while recording same variables. This cycle was repeated every 6 hours for 24 hours. Receives: Other: Mozart music lullaby |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral oxygenation values with and without Mozart music as assessed by near infra red spectroscopy
Using Near infra red spectroscopy electrodes placed over baby's scalp
Measured: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Secondary outcomes (5)
Heart rate
Recorded every minute using continuous stream monitoring by bed master
Measured: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Respiratory rate
Recorded every minute using continuous stream monitoring by bed master
Measured: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Oxygen saturation
Recorded every minute using continuous stream monitoring by bed master
Measured: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Apnea episode
Recorded every minute using continuous stream monitoring by bed master
Measured: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Behavioural response to Mozart music
Continuous video made and later assessed by two developmental nurses and using Newborn Individualized Developmental Care and Assessment Program (NIDCAP)/observation sheet. Both nurses were blinded for time of music as video was mute.
Measured: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Brain OxygenationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coombe Women and Infants University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiza Yasin, Coombe Women and Infants University Hospital
- Investigators
- Faiza Yasin, Principal investigator, Neonatal Department, Coombe Women and Infants University Hospital, Dublin-8,Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471482
- Sponsor's protocol ID
- Study No. 6 - 2013
- Status last verified
- Feb 2016
- First submitted
- 7 Nov 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mozart Music on Cerebral Oxygenation and Behavioural Response of Premature Infants Between 28-32 Weeks of Corrected Gestation
- ClinicalTrials.gov ID
- NCT02471482
- Acronym / sponsor ID
- Study No. 6 - 2013
- Conditions
- Premature Brain Oxygenation
- Keywords
- Near Infra Red Spectrometry, Cerebral oxygenation, Mozart music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coombe Women and Infants University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Jun 2015 (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.
This study is intended to see the effect of Mozart music on oxygen content of brain of premature infants once they achieve corrected gestation of 28-32 weeks and are clinically stable. Each baby is its own control. Difference of Oxygenation of brain will be measured during period with and without music. In addition behavioural response of baby will be recorded during intervention
Detailed description
Study Group:
Stable Infants of corrected age of 28-32weeks will be enrolled at more than seven days age according to inclusion criteria.
An informed written consent will be obtained from parents/guardians after providing information leaflet and verbal explanation.
INCLUSION CRITERIA:
- Babies with corrected age of 28-32(28+0 to32+0) weeks of gestation, more than seven days old
- Breathing spontaneously in room air or stable on nCPAP with FiO2 requirement less than 30%
- Not requiring inotropic support
- On full enteral feeds.
EXCLUSION CRITERIA:
- Babies with major congenital abnormalities
- Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on cranial ultrasound
Study Design:
A randomized crossover study will be conducted in tertiary care level at Coombe Women and Infants University Hospital, Dublin.
As this is a randomized crossover study, each baby will act as his/her own control. Enrolled babies will be randomized to 'Music' or 'No Music'. All babies will be studied one hour after feed. The baby randomized to 'Music' will be played music for 30 minutes with recording of cerebral oxygenation (by using Near infrared spectroscopy) and vital signs (respiratory rate, heart rate, oxygen saturations and frequency of apneic episodes every 10 minutes) followed by 10 minutes of "washout" period and then period of no music for next 30 minutes (with same variables recorded as outlined for music session).
Baby randomized to 'No Music' will have no music in first 30 minutes of study followed by 10 minutes of "washout" period and then 30 minutes of music. This cycle will be repeated every 6 hours for 24 hours.
In addition the investigators will observe the behavioral response of baby during the study period by video recording which will be 'Mute' video recorded and then reviewed by our developmental staff. The behavior will be documented on 'Neonatal Behavioral Observation Sheet'. The observations will include, in addition to vital signs, the facial expression, posture and motor responses of baby during phases of music and no music.
The investigators plan to blind the study to the medical staff and also to the researchers at the time of the study (using research blind mode on near infrared spectroscopy machine). In this mode the data are stored, however not displayed at the time of the study.
Recorded Mozart Lullaby will be played. The noise level will be kept below 45db as recommended by American Academy of Pediatrics and will be monitored by sound monitor placed in incubator during the study period. Enrolled babies will have hearing screening performed prior to discharge from hospital.
Randomization: Sealed opaque envelopes
Music:
The music used will be Mozart Lullaby. This will be played on a small MP3 that will be placed baby's incubator 5cm away from baby's head. The noise level is aimed to be kept under 45dB as per hospital recommendation by adjusting volume of MP3 player. TheMP3 player will be covered in a clean plastic bag for hygiene purpose. The background will be kept to minimum during the study period.
Statistical analysis:
Statistical analysis will be performed using the SPSS software, V.17. Data will be analyzed by t-test to determine significant difference of cerebral blood flow during phase with and without music. Significance will be defined as p<0.05. As there are no data for normal brain oxygenation for the cohort studied, the investigators plan to enroll 30 infants in the pilot phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music First group | Experimental | Other: Mozart music lullabyMozart music lullaby for 30 minutes with recording of cerebral oxygenation (by using Near infrared spectroscopy) and vital signs (respiratory rate, heart rate, oxygen saturations and frequency of apneic episodes continuously) followed by 10 minutes of "washout" period and then period of no music for next 30 minutes (with same variables recorded as outlined for music session). This cycle is repeated every 6 hours for 24 hours. In addition, the behavioral response of baby is observed during the study period by video recording which will be in 'Mute' video mode and then reviewed by our developmental staff |
| No Music First group | Experimental | Other: Mozart music lullabyNo music in first 30 minutes of study followed by 10 minutes of "washout" period and then 30 minutes of Mozart music lullaby while recording same variables. This cycle was repeated every 6 hours for 24 hours. |
Who may qualify
- Ages
- 7 to 35 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Babies with corrected age of 28-32(28+0 to32+0) weeks of gestation, more than seven days old
- Breathing spontaneously in room air or stable on nCPAP with FiO2 requirement less than 30%
- Not requiring inotropic support
- On full enteral feeds.
Key exclusion criteria (2 listed)
- Babies with major congenital abnormalities
- Intraventricular haemorrhage grade 3 and 4 or cystic periventricular leucomalacia on cranial ultrasound
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 |
|---|---|---|
| Mozart music lullabyAlso: MusicRecorded Mozart Lullaby will be played. The noise level will be kept below 45db as recommended by American Academy of Pediatrics and will be monitored by sound monitor placed in incubator during the study period. Enrolled babies will have hearing screening performed prior to discharge from hospital. | Other | Music First group, No Music First group |
Primary outcome
Change in cerebral oxygenation values with and without Mozart music as assessed by near infra red spectroscopy
Time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Using Near infra red spectroscopy electrodes placed over baby's scalp
5 secondary outcomes
Heart rate
Time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Respiratory rate
Time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Oxygen saturation
Time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Apnea episode
Time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Behavioural response to Mozart music
Time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Faiza Yasin principal investigator
Neonatal Department, Coombe Women and Infants University Hospital, Dublin-8,Ireland
Questions about this trial
What is this clinical trial studying?
A study testing Mozart music lullaby in people with Premature Brain Oxygenation, run by Coombe Women and Infants University Hospital.
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 4 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: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in cerebral oxygenation values with and without Mozart music as assessed by near infra red spectroscopy (time frame: One hour after feeding, period of music (assessed up to 30 minutes), wash out period (assessed in next 10 minutes), period of no music (assessed in next 30 minutes). Same cycle would be repeated every six hours for 24 hours only.). 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 23 Feb 2016.