Status:

COMPLETED

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

Lead Sponsor:

Centre Hospitalier Universitaire Dijon

Conditions:

Prematurity

Eye Fundus

Eligibility:

All Genders

1-4 years

Phase:

NA

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 6 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 8 2019

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03830580

Start Date

February 6 2019

End Date

August 8 2019

Last Update

February 23 2024

Active Locations (1)

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Page 1 of 1 (1 locations)

1

CHU Dijon Bourgogne

Dijon, France, 21000

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 | DecenTrialz