Pain of Premature Babies and RetCam (DOLICAM)

NCT04092127 | Completed

• 2 other identifiers: 38RC19.1722019-A01982-55
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Premature Infant Disease; Retinopathy of Prematurity

Keywords

RetCam; Pain evaluation; PIPP (Premature Infant Pain Profile) Score; Screening for Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

  during the usual care procedure of screening of retinopathy of prematurity by RetCam

Study Arms (1)

premature infants (<32 weeks of Gestation Age)

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

Interventions

Video Record OTHER

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

premature infants (<32 weeks of Gestation Age)

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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)
• Having to do a RetCam exam in the neonatology department of the University Hospital of Grenoble.
• No opposition of the subject's parents

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (8)

• 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.

  PMID: 27095887 RESULT

• 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.

  PMID: 22541632 RESULT

• 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.

  PMID: 25081804 RESULT

• 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.

  PMID: 29858451 RESULT

• 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.

  PMID: 24641344 RESULT

• 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.

  PMID: 24500615 RESULT

• 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.

  PMID: 8722730 RESULT

• 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.

  PMID: 20717010 RESULT

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Thierry Debillon, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 17, 2019
• Study Start: November 12, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)