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

Not Applicable

Completed

• Conditions: Eye Fundus; Prematurity
• Interventions: Other: Positive stimulation (singing)

• Registration Number: NCT03830580
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-05
• Study Start: 2019-02-06
• Primary Completion: 2019-08-08
• Study Completion: 2019-08-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sung voice	Positive stimulation (singing)	-

Primary Outcome Measures

Name	Time	Method
Acute pain assessed by the PIPP (Premature Infant Pain Profile) scale	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.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France