Last updated: February 22, 2024
Sponsor: Centre Hospitalier Universitaire Dijon
Overall Status: Completed
Phase
N/A
Condition
Myopic Macular Degeneration
Treatment
Positive stimulation (singing)
Clinical Study ID
NCT03830580
CHARY-TARDY 2018
Ages 1-4 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Infant born prematurely before the end of 31 weeks of amenorrhoea and/or with a birthweight 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 DijonUniversity Hospital
- Infant affiliated to the national medical insurance system
- Oral agreement of one of the two parents
Exclusion
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 thefundus examination because of the risk of decompensation
- Parent refuses the videotaping
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Positive stimulation (singing)
Phase:
Study Start date:
February 06, 2019
Estimated Completion Date:
August 08, 2019
Connect with a study center
CHU Dijon Bourgogne
Dijon, 21000
FranceSite Not Available
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