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 (Voix Chantée)
Primary Purpose
Prematurity, Eye Fundus
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Positive stimulation (singing)
Sponsored by
About this trial
This is an interventional supportive care trial for Prematurity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- CHU Dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sung voice
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03830580
First Posted
January 25, 2019
Last Updated
April 16, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03830580
Brief 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
Acronym
Voix Chantée
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Eye Fundus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sung voice
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Positive stimulation (singing)
Intervention Description
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
Primary Outcome Measure Information:
Title
Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale
Description
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.
Time Frame
During the examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Cécile CHARY-TARDY
Phone
03.80.29.33.62
Email
annececile.charytardy@chu-dijon.fr
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Cécile CHARY-TARDY
Phone
03.80.29.33.62
Email
annececile.charytardy@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
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
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