Retinopathy of PrematurityOMEGAROPNCT02820662
Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born Infants
A study testing RETCAM and Blood samples in people with Retinopathy of Prematurity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of… Read more about this study
- Who is it for?
- Ages 0 to 4 months
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- RETCAM and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2015to 31 May 2018
- Phase
- Interventional
- 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 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant
Who cannot join
- Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns
The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).
- Conditions
- Retinopathy of Prematurity
- Being tested
- RETCAM, Blood samples
- 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.
RETCAMOther
Blood samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| RETCAM | Experimental | Not described Receives: Other: RETCAM; Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005.
Measured: At 4 weeks of life or 31 weeks of amenorrhea
Secondary outcomes (1)
Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start30 Jul 2015
- Primary completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820662
- Sponsor's protocol ID
- KOEHRER APJ 2014
- Acronym
- OMEGAROP
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2016
- Last updated
- 6 Feb 2026
- Results posted
- No
Publications
Pallot C, Soudry Faure A, Charvy C, Ternoy N, Langlet Muteau C, Acar N, Bron AM, Speeg Schatz C, Creuzot-Garcher C. Screening for Retinopathy of Prematurity: Insight into Optimizing Screening. Ophthalmic Res. 2018;59(4):228-234. doi: 10.1159/000477622. Epub 2017 Jul 27.
PubMed 28746942
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns
- ClinicalTrials.gov ID
- NCT02820662
- Acronym / sponsor ID
- OMEGAROP / KOEHRER APJ 2014
- Conditions
- Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 30 Jul 2015 (actual)
- Primary completion
- 31 May 2018 (actual)
- First posted
- 1 Jul 2016 (estimated)
- 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 development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RETCAM | Experimental | Other: RETCAM, Biological: Blood samples |
Who may qualify
- Ages
- 0 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant
Key exclusion criteria (1 listed)
- Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover
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 |
|---|---|---|
| RETCAM | Other | RETCAM |
| Blood samples | Biological | RETCAM |
Primary outcome
Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005.
Time frame: At 4 weeks of life or 31 weeks of amenorrhea
1 secondary outcome
Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.
Time frame: At inclusion
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 6 Feb 2026.
- Results publication: PubMed 28746942Pallot C, Soudry Faure A, Charvy C, Ternoy N, Langlet Muteau C, Acar N, Bron AM, Speeg Schatz C, Creuzot-Garcher C. Screening for Retinopathy of Prematurity: Insight into Optimizing Screening. Ophthalmic Res. 2018;59(4):228-234. doi: 10.1159/000477622. Epub 2017 Jul 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETCAM and Blood samples in people with Retinopathy of Prematurity, run by Centre Hospitalier Universitaire Dijon 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 1 inclusion and 1 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 6 Feb 2026. 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?
Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005. (time frame: At 4 weeks of life or 31 weeks of amenorrhea). 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 NCT02820662, which also lists 1 linked publication.
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 6 Feb 2026.