Other Preterm InfantsNICU-MTNCT04314440
Cognitive Processing in Preterm Infants and NICU Music Therapy
A study testing Music therapy in people with Other Preterm Infants, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
Trial summary
Several positive physiological and behavioural outcomes have been observed in preterm infants exposed to music therapy during their stay at Neonatal Intensive Care Units (NICU). There is ample evidence in the literature showing that brief exposure to music can lead to superior performance on a host of cognitive tasks… Read more about this study
- Who is it for?
- Ages 27 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Other Preterm Infants
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2020
- 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 27 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestation age 27-33 weeks (maternal dates or early fetal ultrasound)
- Is not on ventilators
- Written informed consent forms has been signed from the infant's legal guardian
Who cannot join
- Infants with congenital abnormalities
- Severe intraventricular hemorrhage, with ventriculomegaly or parenchymal hemorrhage
- Infants with known or suspected prenatal exposure to substance
- Infants receiving palliative care at NICU
- Infants who are on ventilators
- Infants whose legal guardian did not sign the consent forms
Trial locations and contacts
1 site in 1 country.
Canada1 site
Regina General Hospital, Neonatal Intensive Care Unit, Deaprtment of Pediatrics
Regina, Saskatchewan
About this study
Several positive physiological and behavioural outcomes have been observed in preterm infants exposed to music therapy during their stay at Neonatal Intensive Care Units (NICU). There is ample evidence in the literature showing that brief exposure to music can lead to superior performance on a host of cognitive tasks in laboratory settings in children, adolescent and adults. However, till date no study has examined the cognitive benefits of NICU music therapy in preterm infants. Further habituation tests have been employed to examine cognitive functioning in infants in laboratory setting but the same test have not been employed as a measure to examine early cognitive functioning in preterm infants.
This project will be carried out to examine the benefits of NICU music therapy on the cognitive functioning of preterm infants born at 27- 33 weeks of gestational age. A randomized controlled research design will be employed to compare cognitive functioning between the treatment and control group at 18 - 24 months of corrected gestational age. The treatment group will be exposed to music therapy during their stay in NICU and the controlled group will be exposed to all standardized care available at our institution except music therapy. Habituation tests will be used to examine cognitive functioning of the preterm infants in groups at 18 - 24 months of gestational age.
Read the detailed description
Following previous research, our hypothesis is that infants in the experimental group will display significantly more positive scores on a collection of physiological and behavioural measurements. The stimuli used at each age will be targeted to the infants' developmental level. Bayley Scales of Infant Development will also be administered at 18 - 24 months as part of high risk infant follow up. These data will be included in the analysis for outcome measurement. While seated in a high-chair or their parent's lap, infants will be habituated to a series of images of a particular shape (e.g., a triangle), while their looking time to each stimulus is measured. Each image during habituation will be a unique token of the category (i.e., all different triangles). Habituation will be individually determined, and defined as cumulative looking across three successive trials that is 50% than cumulative looking across the first three trials. Following habituation, infants will be shown a novel token of the habituation shape (e.g., a new triangle) and a novel shape (e.g., a square), in counterbalanced order. If infants recognize the category change, they should look longer at novel category compared to the novel token. For each test, two dependent measures will be sampled: rate of habituation and amount of dishabituation to the novel category. Mixed ANOVA and paired t-tests will be used to analyze the data. As preterm infants have been shown to be delayed on these kinds of tasks, we hypothesize that the experimental group will habituate to each category faster, and/or display stronger dishabituation scores compared to the preterm. We will also use multiple regression analyses to examine relations between the NICU physiological and behavioural measures and the cognitive measures. We hypothesize that infants who most strongly benefited from their therapies in the NICU will display the most advanced cognitive abilities. An intention-to-treat- analysis will be performed for cognitive measures as well. The cognitive assessment at 2 and 4 months that were to be carried out at the Developmental Lab at University of Regina is now canceled due to feasibility concerns.
- Conditions
- Other Preterm Infants
- Being tested
- Music therapy
- Keywords
- Cognitive, Preterm, Infants, Music, Therapy, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
An accredited music therapist will deliver 15-20 minutes of music therapy every day, 4-5 days in week one and remaining in week two to all MT participants. All participants in music therapy group will get a total of nine sessions. The lullaby "twinkle twinkle little star" will be sung for ~5 minutes, followed by the same songs played on acoustic guitar for ~5 minutes and another ~5 minutes of the same song sung in voice. This protocol will be followed in all 9 sessions for all infants in the experimental arm. The sound levels will be maintained at 55-65 decibels (dB) using appropriate meters. If MT is interrupted within 10 minutes then a make-up session will be delivered, assuming no discharge. In case of missed sessions and interrupted session infants will receive a maximum of 12 session.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Experimental | After the initial warm up session music therapy will be delivered three times a week for 15-20 minutes. All babies in the experimental group will be exposed to three weeks of music therapy sessions that is a total of 9 music therapy session prior to discharge from the hospital. The baby will be placed at the bassinet 15 minutes before music therapy begins. The baby will be in the bassinet during music therapy and 15 minutes post music therapy to allow measurement of physiological indicators. If parents are present during music therapy they will not engage in kangaroo care during the music therapy session or when physiological measurements are being taken pre and post music therapy, but can do so at other times. Receives: Behavioral: Music therapy |
| Control | No intervention | Infants in this group will not receive any music therapy but will receive all other standard care provided to infants at the Regina General Hospital (RGH). All measurements will be carried out for all the infants in this group at the time when observations are carried out for infants in the music therapy group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time looking at a familiar stimulus
Average difference in rate of habituation as measure by the time looking at a familiar stimulus in mili-seconds between experimental and control groups.
Measured: 18 - 24 months
Secondary outcomes (7)
Physiological measure
Average difference in heart rate before music therapy to after music therapy from before to during and from during to after music therapy.
Measured: 15 minutes,before, during, after music therapy, 6 days a week
Physiological measure
Average difference in breathing rate before music therapy to after music therapy from before to during and from during to after music therapy.
Measured: 15 minutes,before, during, after music therapy, 6 days a week
Physiological measure
Average difference in oxygen saturation before music therapy to after music therapy from before to during and from during to after music therapy.
Measured: 15 minutes,before, during, after music therapy, 6 days a week
Behavioral measure
Difference in sleep between experimental and control group
Measured: Before to after music therapy 6 days a week
Behavioral measure
Difference in apnea between experimental and control group
Measured: Before to after music therapy 6 days a week
Behavioral measure
Difference in Bradycardia (number and severity) between experimental and control group
Measured: Before to after music therapy 6 days a week
Behavioral measure
Difference in de-saturation degree of it between experimental and control group
Measured: Before to after music therapy 6 days a week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Preterm InfantsStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regina
- Responsible party
- Sponsor
- Investigators
- Jayalakshmi Bodani, Principal investigator, Saskatchewan Health Authority - Regina Area
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314440
- Sponsor's protocol ID
- REB15-100
- Acronym
- NICU-MT
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing in Preterm Infants and NICU Music Therapy
- ClinicalTrials.gov ID
- NCT04314440
- Acronym / sponsor ID
- NICU-MT / REB15-100
- Conditions
- Other Preterm Infants
- Keywords
- Cognitive, Preterm, Infants, Music, Therapy, NICU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Saskatchewan Health Authority - Regina AreaUniversity, hospital or other
- Collaborators
- University of Regina
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Mar 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.
Several positive physiological and behavioural outcomes have been observed in preterm infants exposed to music therapy during their stay at Neonatal Intensive Care Units (NICU). There is ample evidence in the literature showing that brief exposure to music can lead to superior performance on a host of cognitive tasks in laboratory settings in children, adolescent and adults. However, till date no study has examined the cognitive benefits of NICU music therapy in preterm infants. Further habituation tests have been employed to examine cognitive functioning in infants in laboratory setting but the same test have not been employed as a measure to examine early cognitive functioning in preterm infants.
This project will be carried out to examine the benefits of NICU music therapy on the cognitive functioning of preterm infants born at 27- 33 weeks of gestational age. A randomized controlled research design will be employed to compare cognitive functioning between the treatment and control group at 18 - 24 months of corrected gestational age. The treatment group will be exposed to music therapy during their stay in NICU and the controlled group will be exposed to all standardized care available at our institution except music therapy. Habituation tests will be used to examine cognitive functioning of the preterm infants in groups at 18 - 24 months of gestational age.
Detailed description
Following previous research, our hypothesis is that infants in the experimental group will display significantly more positive scores on a collection of physiological and behavioural measurements. The stimuli used at each age will be targeted to the infants' developmental level. Bayley Scales of Infant Development will also be administered at 18 - 24 months as part of high risk infant follow up. These data will be included in the analysis for outcome measurement. While seated in a high-chair or their parent's lap, infants will be habituated to a series of images of a particular shape (e.g., a triangle), while their looking time to each stimulus is measured. Each image during habituation will be a unique token of the category (i.e., all different triangles). Habituation will be individually determined, and defined as cumulative looking across three successive trials that is 50% than cumulative looking across the first three trials. Following habituation, infants will be shown a novel token of the habituation shape (e.g., a new triangle) and a novel shape (e.g., a square), in counterbalanced order. If infants recognize the category change, they should look longer at novel category compared to the novel token. For each test, two dependent measures will be sampled: rate of habituation and amount of dishabituation to the novel category. Mixed ANOVA and paired t-tests will be used to analyze the data. As preterm infants have been shown to be delayed on these kinds of tasks, we hypothesize that the experimental group will habituate to each category faster, and/or display stronger dishabituation scores compared to the preterm. We will also use multiple regression analyses to examine relations between the NICU physiological and behavioural measures and the cognitive measures. We hypothesize that infants who most strongly benefited from their therapies in the NICU will display the most advanced cognitive abilities. An intention-to-treat- analysis will be performed for cognitive measures as well. The cognitive assessment at 2 and 4 months that were to be carried out at the Developmental Lab at University of Regina is now canceled due to feasibility concerns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Experimental | Behavioral: Music therapyAfter the initial warm up session music therapy will be delivered three times a week for 15-20 minutes. All babies in the experimental group will be exposed to three weeks of music therapy sessions that is a total of 9 music therapy session prior to discharge from the hospital. The baby will be placed at the bassinet 15 minutes before music therapy begins. The baby will be in the bassinet during music therapy and 15 minutes post music therapy to allow measurement of physiological indicators. If parents are present during music therapy they will not engage in kangaroo care during the music therapy session or when physiological measurements are being taken pre and post music therapy, but can do so at other times. |
| Control | No intervention | –Infants in this group will not receive any music therapy but will receive all other standard care provided to infants at the Regina General Hospital (RGH). All measurements will be carried out for all the infants in this group at the time when observations are carried out for infants in the music therapy group. |
Who may qualify
- Ages
- 27 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestation age 27-33 weeks (maternal dates or early fetal ultrasound)
- Is not on ventilators
- Written informed consent forms has been signed from the infant's legal guardian
Key exclusion criteria (6 listed)
- Infants with congenital abnormalities
- Severe intraventricular hemorrhage, with ventriculomegaly or parenchymal hemorrhage
- Infants with known or suspected prenatal exposure to substance
- Infants receiving palliative care at NICU
- Infants who are on ventilators
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 therapyAn accredited music therapist will deliver 15-20 minutes of music therapy every day, 4-5 days in week one and remaining in week two to all MT participants. All participants in music therapy group will get a total of nine sessions. The lullaby "twinkle twinkle little star" will be sung for ~5 minutes, followed by the same songs played on acoustic guitar for ~5 minutes and another ~5 minutes of the same song sung in voice. This protocol will be followed in all 9 sessions for all infants in the experimental arm. The sound levels will be maintained at 55-65 decibels (dB) using appropriate meters. If MT is interrupted within 10 minutes then a make-up session will be delivered, assuming no discharge. In case of missed sessions and interrupted session infants will receive a maximum of 12 session. | Behavioural | Music therapy |
Primary outcome
Time looking at a familiar stimulus
Time frame: 18 - 24 months
Average difference in rate of habituation as measure by the time looking at a familiar stimulus in mili-seconds between experimental and control groups.
7 secondary outcomes
Physiological measure
Time frame: 15 minutes,before, during, after music therapy, 6 days a week
Physiological measure
Time frame: 15 minutes,before, during, after music therapy, 6 days a week
Physiological measure
Time frame: 15 minutes,before, during, after music therapy, 6 days a week
Behavioral measure
Time frame: Before to after music therapy 6 days a week
Behavioral measure
Time frame: Before to after music therapy 6 days a week
Behavioral measure
Time frame: Before to after music therapy 6 days a week
Behavioral measure
Time frame: Before to after music therapy 6 days a week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Individual participant dataSharing planned: Yes
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
RecruitingObservational study
Multi-observational Study for the Early Identification of Autism Spectrum Disorder (ASD) and Other Neurodevelopmental Disorders (NDD) in At-risk Populations
Autism Spectrum Disorder (ASD), Neurodevelopmental Disorders
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.
Jayalakshmi Bodani principal investigator
Saskatchewan Health Authority - Regina Area
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 therapy in people with Other Preterm Infants, run by Saskatchewan Health Authority - Regina Area at 1 site in Canada.
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 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 19 Mar 2020. 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 Canada. 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?
Time looking at a familiar stimulus (time frame: 18 - 24 months). 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 19 Mar 2020.