Pain of Premature Babies and RetCam (DOLICAM)

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Premature Infant Disease, Retinopathy of Prematurity

Intervention / Treatment
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* Other: Video Record


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| premature infants (<32 weeks of Gestation Age)<br>premature babies (<32 weeks of Gestation Age) to be screened with RetCam for retinopathy of prematurity and who will be filmed during the screening procedure to evaluate pain with the PIPP score (Premature Infant Pain Profile) | Other: Video Record<br>* Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain quantification with the PIPP (Premature Infant Pain Profile) scale during a screening for retinopathy of prematurity with RetCam (with the analgesic protocol set up in the neonatology department of the University Hospital of Grenoble) | the highest value of pain assessment by the PIPP (Premature Infant Pain Profile) scale during the RetCam exam. The 2 assessments will be done: after eyelid speculum placement (30 seconds evaluation) after RetCam installation (30s) PIPP: the higher is the score, the higher the pain is. Total score (from 0 to 21) = addition of 7 subscores (0-3): Gestational Age: 36 weeks or more / 32-35 weeks + 6 days / 28-31 weeks + 6 days / Less than 28 weeks Behavioural State: Active, awake, eyes open, facial, movement / Quiet awake, eyes open, no facial movements / Active sleep, eyes closed, facial movements / Quiet sleep, eyes closed, no facial movements heart rate maximum: 0 bpm (beats per minute) increase / 5-15 bpm increase / 15-24 bpm increase / 25+ bpm increase. oxygen saturation minimum: 92-100%/89-91%/88-85%/<85% Brow Bulge: None/Minimum/Moderate/Maximum Eye Squeeze: None/Minimum/Moderate/Maximum Naso-labial furrow: None/Minimum/Moderate/Maximum | during the screening of retinopathy of prematurity by RetCam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the most painful part of the examination : Comparison of the pain felt when the eyelid speculums are placed and the pain felt during during the examination by the RetCam (during the same gesture). | Numerical value of PIPP 30 seconds after eyelid speculum placement compared to the PIPP numerical value of 30 seconds after the start of the camera examination. PIPP: the higher is the score, the higher the pain is. Total score (from 0 to 21) = addition of 7 subscores (0-3): Gestational Age: 36 weeks or more / 32-35 weeks + 6 days / 28-31 weeks + 6 days / Less than 28 weeks Behavioural State: Active, awake, eyes open, facial, movement / Quiet awake, eyes open, no facial movements / Active sleep, eyes closed, facial movements / Quiet sleep, eyes closed, no facial movements heart rate maximum: 0 bpm (beats per minute) increase / 5-15 bpm increase / 15-24 bpm increase / 25+ bpm increase. oxygen saturation minimum: 92-100%/89-91%/88-85%/<85% Brow Bulge: None/Minimum/Moderate/Maximum Eye Squeeze: None/Minimum/Moderate/Maximum Naso-labial furrow: None/Minimum/Moderate/Maximum | during the usual care procedure of screening of retinopathy of prematurity by RetCam | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RetCam, Pain evaluation, PIPP (Premature Infant Pain Profile) Score, Screening for Retinopathy of Prematurity