We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain of Premature Babies and RetCam (DOLICAM) (DOLICAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092127
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, 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).


Condition or disease Intervention/treatment
Premature Infant Disease Retinopathy of Prematurity Other: Video Record

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam
Actual Study Start Date : November 12, 2019
Actual Primary Completion Date : June 15, 2020
Actual Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092127


Locations
Layout table for location information
France
Chu Grenoble Alpes
Grenoble Cedex 9, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Thierry Debillon, MD PhD University Hospital, Grenoble
Publications of Results:

Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04092127    
Other Study ID Numbers: 38RC19.172
2019-A01982-55 ( Other Identifier: ID RCB )
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
RetCam
Pain evaluation
PIPP (Premature Infant Pain Profile) Score
Screening for Retinopathy of Prematurity
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Eye Diseases
Infant, Newborn, Diseases