NCT04092127

Pain of Premature Babies and RetCam (DOLICAM)

Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

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 whom the RetCam examination is planned for screening for retinopathy of prematurity if they are at risk (prematurity \<32 weeks). To measure their pain during the examination, it will be a matter of filming the face of the child for 15 seconds before the examination, then 2 times 30 seconds at two distinct times. The PIPP (Premature Infant Pain Profile) score includes a percentage of time on these 30 seconds where 3 items are found modified and a monitoring of heart rate and oxygen saturation.This time calculation can not be done live and requires video recording of the child's face during the exam. The statistical analyzes will be adjusted for sex, gestational age at birth, weight, and pain from birth (determined by the number of doses of level 1 analgesics received by the baby and the number of days (from birth to to the RetCam examination) when the baby received \> level 1 analgesics).

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 for whom the RetCam examination is planned for screening for retinopathy of prematurity if they are at risk (prematurity \<32 weeks). These exams fit into a routine care. To measure their pain during the examination, it will be a matter of filming the face of the child for 15 seconds before the examination, then 2 times 30 seconds at two distinct times. The PIPP (Premature Infant Pain Profile) score includes a percentage of time on these 30 seconds where 3 items are found modified and a monitoring of heart rate and oxygen saturation. (Please note that the recording of the constants of the child is already integrated into the current care in the neonatology department of the University Hospital of Grenoble and will not be added for the purpose of the study.) Expected scores should be about 12/21, despite the use of analgesic agent. This time calculation can not be done live and requires video recording of the child's face during the exam. After parental information and non-opposition consent of the parents, the child can be filmed and his constants annotated during the current care. Parents can attend this observational procedure. The statistical analyzes will be adjusted for sex, gestational age at birth, weight, and pain from birth (determined by the number of doses of level 1 analgesics received by the baby and the number of days (from birth to to the RetCam examination) when the baby received \> level 1 analgesics).

Conditions

• Premature Infant Disease
• Retinopathy of Prematurity

Interventions

Type	Name	Description
OTHER	Video Record	Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity

Timeline

• Start date: 2019-11-12
• Primary completion: 2020-06-15
• Completion: 2020-06-15
• First posted: 2019-09-17
• Last updated: 2022-06-14

Locations

1 site across 1 country: France