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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1
CHU Dijon Bourgogne
Dijon, France, 21000