Retinopathy of Prematurity Clinical Trial
Official title:
Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam
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).
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). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05043077 -
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening
|
Phase 4 | |
Completed |
NCT04838665 -
Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study
|
Phase 4 | |
Completed |
NCT04408807 -
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
|
N/A | |
Recruiting |
NCT03083431 -
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
|
Phase 2 | |
Enrolling by invitation |
NCT04985448 -
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
|
||
Recruiting |
NCT02090322 -
Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1
|
N/A | |
Completed |
NCT00872664 -
Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids
|
N/A | |
Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT06452524 -
Prematurity and Ophthalmological Changes
|
||
Completed |
NCT04101721 -
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
|
Phase 3 | |
Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 | |
Terminated |
NCT01335113 -
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
|
||
Active, not recruiting |
NCT00027222 -
The Early Treatment for Retinopathy of Prematurity Study (ETROP)
|
Phase 2/Phase 3 | |
Recruiting |
NCT06109285 -
Validation of i-ROP DL to Detect More Than Mild ROP
|
N/A | |
Completed |
NCT02014454 -
Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
|
Phase 2 | |
Completed |
NCT01861470 -
REDEXAM - Reducing Painful Eye Examinations in Preterm Infants
|
N/A | |
Terminated |
NCT00634972 -
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity
|
Phase 4 | |
Completed |
NCT05701124 -
Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity
|
Phase 3 | |
Completed |
NCT04621136 -
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
|
Phase 1/Phase 2 | |
Completed |
NCT04883931 -
Mother Milk as a Eye Drop & Premature Retinopathy
|
N/A |