Status:
COMPLETED
Pain of Premature Babies and RetCam (DOLICAM)
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Premature Infant Disease
Retinopathy of Prematurity
Eligibility:
All Genders
Up to 4 years
Brief Summary
It is a single-center prospective observational descriptive study. studied population is premature infants, hospitalized in the neonatology department of the University Hospital of Grenoble and for w...
Detailed Description
It is a single-center prospective observational descriptive study. The studied children will be premature infants hospitalized in the neonatology department of the University Hospital of Grenoble and...
Eligibility Criteria
Inclusion
- Premature born before 31 weeks of Gestational Age or birth weight less than 1250 grams or less than 1300 grams and less than 33 weeks of Gestational age, with risk factor (prolonged oxygen therapy, sepsis, prolonged use of inotropes)
- Corrected age above 31 weeks of gestational age at the time of inclusion
- Having to do a RetCam exam in the neonatology department of the University Hospital of Grenoble.
- No opposition of the subject's parents
Exclusion
- Subject under guardianship or subject deprived of liberty
- Premature requiring a respiratory aid limiting the observation of the face at the time of the examination.
- Non-compliance with the analgesic protocol of the service, prior to examination (paracetamol and sugar solutions).
- Prematurity with a facial malformation and / or neurological disorder that prevents the rating of pain by the PIPP scale
Key Trial Info
Start Date :
November 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2020
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04092127
Start Date
November 12 2019
End Date
June 15 2020
Last Update
June 14 2022
Active Locations (1)
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1
Chu Grenoble Alpes
Grenoble, France, 38043