CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Video Recordother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04092127
NCT04092127N/ACompleted

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

University Hospital, Grenoble·observational·Posted Sep 17, 2019·Updated Jun 14, 2022

In Brief

An observational study evaluating Video Record for Premature Infant Disease and Retinopathy of Prematurity. Completed, enrolled 31 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 17, 2019
Enrollment StartNov 12, 2019
Primary CompletionJun 15, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.8 years ago

Interventions

Video Recordother

Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity