Premature Infant DiseaseDOLICAMNCT04092127
Pain of Premature Babies and RetCam (DOLICAM)
An observational study of Premature Infant Disease and Retinopathy of Prematurity, run by University Hospital, Grenoble at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Premature Infant Disease, Retinopathy of Prematurity
- What is being tested?
- Video Record
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2019to 15 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam
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).
Read more
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).
Read the 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).
- Being tested
- Video Record
- Keywords
- RetCam, Pain evaluation, PIPP (Premature Infant Pain Profile) Score, Screening for Retinopathy of Prematurity
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video RecordOther
Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Video Record |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
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
Measured: during the usual care procedure of screening of retinopathy of prematurity by RetCam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study start12 Nov 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Premature Infant DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Debillon, MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04092127
- Sponsor's protocol ID
- 38RC19.172
- Other IDs
- 2019-A01982-55
- Acronym
- DOLICAM
- Status last verified
- Jun 2022
- First submitted
- 10 Sep 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27095887Chiang 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.
PubMed 22541632Ezz 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.
PubMed 25081804Disher 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.
PubMed 29858451Ranger 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.
PubMed 24641344Vinall 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.
PubMed 24500615Stevens 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.
PubMed 8722730Stevens 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.
PubMed 20717010
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Quantification Study During a Screening for Retinopathy of Premature Babies by RetCam
- ClinicalTrials.gov ID
- NCT04092127
- Acronym / sponsor ID
- DOLICAM / 38RC19.172
- Keywords
- RetCam, Pain evaluation, PIPP (Premature Infant Pain Profile) Score, Screening for Retinopathy of Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 17 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature infants (<32 weeks of Gestation Age) | – | Other: Video Recordpremature 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) |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video RecordVideo Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity | Other | premature infants (<32 weeks of Gestation Age) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Results publication: PubMed 27095887Jefferies 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.
- Results publication: PubMed 22541632Chiang 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.
- Results publication: PubMed 25081804Ezz 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.
- Results publication: PubMed 29858451Disher 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.
- Results publication: PubMed 24641344Ranger 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.
- Results publication: PubMed 24500615Vinall 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.
- Results publication: PubMed 8722730Stevens 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.
- Results publication: PubMed 20717010Stevens 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Debillon, MD PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant Disease and Retinopathy of Prematurity, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: during the screening of retinopathy of prematurity by RetCam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04092127, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.