Clinical trial NCT04092127: Pain of Premature Babies and RetCam (DOLICAM)
Official title: Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Infant Disease
Retinopathy of Prematurity
Keywords: RetCam
Pain evaluation
PIPP (Premature Infant Pain Profile) Score
Screening for Retinopathy of Prematurity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 31
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The studied population corresponds to the premature infants of more than 31 weeks of gestational age and of more than 4 weeks of life, which require a retinopathy of the premature screening by RetCam in the service of neonatology, neonatal resuscitation of the University Hospital of Grenoble

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 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).

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: during the screening of retinopathy of prematurity by RetCam
Secondary outcomes:
measure: 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).
timeFrame: during the usual care procedure of screening of retinopathy of prematurity by RetCam
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Chu Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Thierry Debillon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee. Retinopathy of prematurity: An update on screening and management. Paediatr Child Health. 2016 Mar;21(2):101-8. doi: 10.1093/pch/21.2.101.
citation: Chiang MF, Melia M, Buffenn AN, Lambert SR, Recchia FM, Simpson JL, Yang MB. Detection of clinically significant retinopathy of prematurity using wide-angle digital retinal photography: a report by the American Academy of Ophthalmology. Ophthalmology. 2012 Jun;119(6):1272-80. doi: 10.1016/j.ophtha.2012.01.002. Epub 2012 Apr 27.
citation: Ezz El Din ZM, El Sada MA, Ali AA, Al Husseiny K, Yousef AA. Comparison of digital imaging screening and indirect ophthalmoscopy for retinopathy of prematurity. Indian J Pediatr. 2015 Jan;82(1):80-3. doi: 10.1007/s12098-014-1525-1. Epub 2014 Aug 1.
citation: Disher T, Cameron C, Mitra S, Cathcart K, Campbell-Yeo M. Pain-Relieving Interventions for Retinopathy of Prematurity: A Meta-analysis. Pediatrics. 2018 Jul;142(1):e20180401. doi: 10.1542/peds.2018-0401. Epub 2018 Jun 1.
citation: Ranger M, Grunau RE. Early repetitive pain in preterm infants in relation to the developing brain. Pain Manag. 2014 Jan;4(1):57-67. doi: 10.2217/pmt.13.61.
citation: Vinall J, Grunau RE. Impact of repeated procedural pain-related stress in infants born very preterm. Pediatr Res. 2014 May;75(5):584-7. doi: 10.1038/pr.2014.16. Epub 2014 Feb 5.
citation: Stevens B, Johnston C, Petryshen P, Taddio A. Premature Infant Pain Profile: development and initial validation. Clin J Pain. 1996 Mar;12(1):13-22. doi: 10.1097/00002508-199603000-00004.
citation: Stevens B, Johnston C, Taddio A, Gibbins S, Yamada J. The premature infant pain profile: evaluation 13 years after development. Clin J Pain. 2010 Nov-Dec;26(9):813-30. doi: 10.1097/AJP.0b013e3181ed1070.