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Completed

NCT Number: NCT04092127

Pain of Premature Babies and RetCam (DOLICAM)

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).

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Key information

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Grenoble Alpes

Grenoble, 38043, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Record

Other

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

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)

    Time frame: during the screening of retinopathy of prematurity by RetCam

    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

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).

    Time frame: during the usual care procedure of screening of retinopathy of prematurity by RetCam

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: DOLICAM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2019
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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