Retinopathy of PrematurityDEREP3NCT05152862
Improve Screening Criteria for Retinopathy of Prematurity in Two French Center
An observational study of Retinopathy of Prematurity, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of… Read more about this study
- Who is it for?
- Ages 0 years to 31 weeks
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Laser and Anti VEGF
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 886 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2022to 16 Jun 2022
- 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 0 years to 31 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Cohort will be selected among all premature born between January 2016 and November 2020 and hospitalized in Centre Hospitalier Sud Francilien (Corbeil Essonnes 91) and Hopital Robert Debré (Paris 75).
Who may be able to join
- Infant with gestational age < 31 weeks and/or birth weight < 1250 g
- With at least one retinal examination
- holders of the parental rights informed and not objecting to the study
Who cannot join
- infants died before 28 days PNA
- infants with hydrocephaly.
- infants with significant congenital malformations or genetic abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Criteria and Modalities of Screening for Retinopathy of Prematurity in Two French Tertiary NICU : is a Simplification Possible ?
The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.
Read the detailed description
Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children worldwide. Despite a stable incidence over the last decades, improvements in neonatal care and survival of extremely premature lead to an increased screening and follow up of ROP. Retinal examination is painful and can result in clinical deterioration, it also generates significant health care costs. In this way, several studies suggest the need to optimize screening without ignoring severe ROP requiring treatment. Recently, SCREENROP in Canada and SWEDROP studies in Sweden contributed to a modification of the national screening guidelines with a reducing upper limit at 30 weeks of gestational age (GA) and a postponing of the first examination. Because of the population studied, those recommendations cannot be applicable in other countries.
Recommendations in France are to screen infants < 31 GA or 1250 g, first examination should be performed at PMA 31 in infants < 27 GA and at 4 weeks postnatal age (PNA) in infants born at 27 GA or more. Our main hypothesis is that a reduction of the screening criteria by decreasing the upper limit of the threshold at 30 GA and/or postponing the first examination is acceptable in a population of premature newborns from two French tertiary NICU. This simplification of the screening modalities could reduced the number of fundus examinations performed, while limiting risks for the patient as well as costs. This study could be a pilot study for a national multicenter trial, with the objective of revising national screening guidelines.
- Conditions
- Retinopathy of Prematurity
- Being tested
- Laser, Anti VEGF
- Keywords
- birth weight, gestational age, premature, retina, screening
- Medical subject headings
- Retinopathy of Prematurity, Birth Weight, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserProcedure or surgery
Retinal laser photocoagulation
Anti VEGFProcedure or surgery
Anti-VEGF intravitreous injection
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants with type 1 or 2 ROP found at routine screening.
Number
Measured: Day 0
Secondary outcomes (3)
Time from first retinal examination to treatment of ROP
days
Measured: Day 0
Postnatal age / SAC at first by gestational age
days
Measured: Day 0
Time from first retinal examination to diagnostic of severe ROP
days
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start21 Mar 2022
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline LEROUX, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152862
- Sponsor's protocol ID
- 2021/0053
- Acronym
- DEREP3
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Criteria and Modalities of Screening for Retinopathy of Prematurity in Two French Tertiary NICU : is a Simplification Possible ?
- ClinicalTrials.gov ID
- NCT05152862
- Acronym / sponsor ID
- DEREP3 / 2021/0053
- Conditions
- Retinopathy of Prematurity
- Keywords
- birth weight, gestational age, premature, retina, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 10 Dec 2021 (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.
The aim of the study is to assess whether a delay of the first examination can be safely considered in French population. Secondary objectives are to describe retinopathy of prematurity (ROP) in a population of premature from two French tertiary NICU and to identify co-morbidities associated with the development of severe ROP.
Detailed description
Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children worldwide. Despite a stable incidence over the last decades, improvements in neonatal care and survival of extremely premature lead to an increased screening and follow up of ROP. Retinal examination is painful and can result in clinical deterioration, it also generates significant health care costs. In this way, several studies suggest the need to optimize screening without ignoring severe ROP requiring treatment. Recently, SCREENROP in Canada and SWEDROP studies in Sweden contributed to a modification of the national screening guidelines with a reducing upper limit at 30 weeks of gestational age (GA) and a postponing of the first examination. Because of the population studied, those recommendations cannot be applicable in other countries.
Recommendations in France are to screen infants < 31 GA or 1250 g, first examination should be performed at PMA 31 in infants < 27 GA and at 4 weeks postnatal age (PNA) in infants born at 27 GA or more. Our main hypothesis is that a reduction of the screening criteria by decreasing the upper limit of the threshold at 30 GA and/or postponing the first examination is acceptable in a population of premature newborns from two French tertiary NICU. This simplification of the screening modalities could reduced the number of fundus examinations performed, while limiting risks for the patient as well as costs. This study could be a pilot study for a national multicenter trial, with the objective of revising national screening guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Cohort will be selected among all premature born between January 2016 and November 2020 and hospitalized in Centre Hospitalier Sud Francilien (Corbeil Essonnes 91) and Hopital Robert Debré (Paris 75).
Key inclusion criteria (3 listed)
- Infant with gestational age < 31 weeks and/or birth weight < 1250 g
- With at least one retinal examination
- holders of the parental rights informed and not objecting to the study
Key exclusion criteria (3 listed)
- infants died before 28 days PNA
- infants with hydrocephaly.
- infants with significant congenital malformations or genetic abnormalities.
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 |
|---|---|---|
| LaserRetinal laser photocoagulation | Procedure or surgery | – |
| Anti VEGFAnti-VEGF intravitreous injection | Procedure or surgery | – |
Primary outcome
Number of infants with type 1 or 2 ROP found at routine screening.
Time frame: Day 0
Number
3 secondary outcomes
Time from first retinal examination to treatment of ROP
Time frame: Day 0
Postnatal age / SAC at first by gestational age
Time frame: Day 0
Time from first retinal examination to diagnostic of severe ROP
Time frame: Day 0
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 26 Nov 2024.
- 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.
Pauline LEROUX, MD principal investigator
Centre Hospitalier Sud Francilien
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 Retinopathy of Prematurity, run by Centre Hospitalier Sud Francilien 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 3 inclusion and 3 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 26 Nov 2024. 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?
Number of infants with type 1 or 2 ROP found at routine screening. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.