Clinical trial NCT03830580: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Eye Fundus
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale
timeFrame: During the examination
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: