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

NCT ID: NCT03830580

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2019-08-08

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.

Conditions

Prematurity; Eye Fundus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sung voice

Group Type: EXPERIMENTAL

Positive stimulation (singing)

Intervention Type: 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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

CHARY-TARDY 2018

Identifier Type: -

Identifier Source: org_study_id