PrematurityVoix ChantéeNCT03830580
Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital
A study testing Positive stimulation (singing) in people with Prematurity and Eye Fundus, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. Read more about this study
- Who is it for?
- Ages 1 month to 4 months
- Conditions the study is for
- Prematurity, Eye Fundus
- What is being tested?
- Positive stimulation (singing)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2019to 8 Aug 2019
- 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 1 month to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birth weight of less than 1250g
- Infant in whom a first screening examination (fundus) for retinopathy of prematurity (i.e. around 32 WA) must be carried out according to term by hospital protocol
- Infant hospitalized in the neonatal paediatrics and intensive care unit of the Dijon University Hospital
- Infant affiliated to the national medical insurance system
- Oral agreement of one of the two parents
Who cannot join
- Infants with contraindications to the use of Algopedol® 24% sugar solution, NEOSYNEPHRINE 2.5% mydriatic eye drops for pupillary dilatation, MYDRIATICUM 0.5% mydriatic eye drops for pupillary dilatation and OXYBUPROCAINE analgesic eye drops
- Infant with known deafness and no hearing aid
- Premature infant in critical condition
- Infant with hemodynamic and clinical instability making it impossible to perform the fundus examination because of the risk of decompensation
- Parent refuses the videotaping
Trial locations and contacts
1 site in 1 country.
About this study
As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time.
The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination.
Read more
To do this, the participating children will be divided into 2 groups:
- The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time
- control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.
- Conditions
- Prematurity, Eye Fundus
- Being tested
- Positive stimulation (singing)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive stimulation (singing)Other
A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction
| Study group | Role | What they receive |
|---|---|---|
| Sung voice | Experimental | Not described Receives: Other: Positive stimulation (singing) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale
The children's faces and bodies will be filmed - without sound - during the examination. The nurse who examines the fundus will start and finish the video recording.
Measured: During the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start6 Feb 2019
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830580
- Sponsor's protocol ID
- CHARY-TARDY 2018
- Acronym
- Voix Chantée
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2019
- Last updated
- 23 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Singing in the Care of Premature Children Undergoing Screening for Retinopathy of Prematurity in the Neonatology and Neonatal Resuscitation Unit of the Dijon University Hospital
- ClinicalTrials.gov ID
- NCT03830580
- Acronym / sponsor ID
- Voix Chantée / CHARY-TARDY 2018
- Conditions
- Prematurity, Eye Fundus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 5 Feb 2019 (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.
As part of the regular procedure for premature births, premature infants undergo several screening examinations, including an examination of the fundus. This examination seeks to establish whether the infant has retinopathy of prematurity. This disease affects the vessels of the retina of the eye, especially in prematurely born children, and can lead to serious complications such as blindness if it is not treated in time.
The purpose of this study is to assess the discomfort caused by the screening in order to improve practices. To do this, the investigators would like to evaluate whether soft auditory stimulation, more precisely a person singing, would improve the children's level of comfort during the examination.
To do this, the participating children will be divided into 2 groups:
- The "Singing" group will receive the usual comfort treatments (placed in a 'nest', pacifier and sugar water) and a trained professional will sing a lullaby or nursery rhyme at the same time
- control group will receive the usual comfort care (placed in a 'nest', pacifier and sugar water) The child's head and entire body will be filmed, which will allow an evaluator to assess the child's comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sung voice | Experimental | Other: Positive stimulation (singing) |
| Control | No intervention | – |
Who may qualify
- Ages
- 1 month to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birth weight of less than 1250g
- Infant in whom a first screening examination (fundus) for retinopathy of prematurity (i.e. around 32 WA) must be carried out according to term by hospital protocol
- Infant hospitalized in the neonatal paediatrics and intensive care unit of the Dijon University Hospital
- Infant affiliated to the national medical insurance system
- Oral agreement of one of the two parents
Key exclusion criteria (5 listed)
- Infants with contraindications to the use of Algopedol® 24% sugar solution, NEOSYNEPHRINE 2.5% mydriatic eye drops for pupillary dilatation, MYDRIATICUM 0.5% mydriatic eye drops for pupillary dilatation and OXYBUPROCAINE analgesic eye drops
- Infant with known deafness and no hearing aid
- Premature infant in critical condition
- Infant with hemodynamic and clinical instability making it impossible to perform the fundus examination because of the risk of decompensation
- Parent refuses the videotaping
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 |
|---|---|---|
| Positive stimulation (singing)A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction | Other | Sung voice |
Primary outcome
Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale
Time frame: During the examination
The children's faces and bodies will be filmed - without sound - during the examination. The nurse who examines the fundus will start and finish the video recording.
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 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive stimulation (singing) in people with Prematurity and Eye Fundus, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 5 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 2024. 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 France. 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 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?
Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale (time frame: During the examination). 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 2024.