PrematurityOMEGAROP 2NCT04819893
Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.
An observational study of Prematurity and Retinopathy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prematurity, Retinopathy
- What is being tested?
- Maternal blood sampling, Umbilical cord blood sampling and Placenta sampling
- How many people
- 135 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2021to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Women giving birth at term or prematurely
Who may be able to join
- Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.
- Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.
- ≥18 years
- Mothers not under legal protection
Who cannot join
- Mothers giving birth between 29WA and 38WA+6 days
- Mothers in critical condition.
- Person not affiliated to national health insurance
- For full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourogne
Dijon, 21000
Chloé Carré, ccarre34@gmail.com
About this study
The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.
- Conditions
- Prematurity, Retinopathy
- Being tested
- Maternal blood sampling, Umbilical cord blood sampling, Placenta sampling, Data collection
- Medical subject headings
- Premature Birth, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal blood samplingBiological
5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols
Umbilical cord blood samplingBiological
0.5mL sample from the umbilical cord after childbirth standard protocols
Placenta samplingBiological
Sampling of 3 cotyledons by cutting across the thickness of the placenta
Data collectionOther
Newborn, Maternal and Premature Retinopathy Screening Data Collection
| Study group | Role | What they receive |
|---|---|---|
| Women giving birth prematurely | Delivery before 29 WA Receives: Biological: Maternal blood sampling; Biological: Umbilical cord blood sampling; Biological: Placenta sampling; Other: Data collection | |
| Women giving birth at term | Childbirth between 39WA and 31WA+6 days Receives: Biological: Maternal blood sampling; Biological: Umbilical cord blood sampling; Biological: Placenta sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery
Measured: 16 weeks maximum after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Apr 2021
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
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
- NCT04819893
- Sponsor's protocol ID
- CREUZOT-GARCHER 2020-1
- Acronym
- OMEGAROP 2
- Status last verified
- Sep 2025
- First submitted
- 25 Mar 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carre C, Acar N, Daruich A, Gregoire S, Martine L, Buteau B, Aho S, Eid P, Arnould L, Bron AM, Driessen M, Kermorvant E, Simon E, Creuzot-Garcher C, Gabrielle PH. Study protocol of OmegaROP-2 prospective study: expression of placental fatty acid receptors in preterm newborns with retinopathy of prematurity. BMC Ophthalmol. 2023 Oct 6;23(1):404. doi: 10.1186/s12886-023-03156-0.
PubMed 37803473
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.
- ClinicalTrials.gov ID
- NCT04819893
- Acronym / sponsor ID
- OMEGAROP 2 / CREUZOT-GARCHER 2020-1
- Conditions
- Prematurity, Retinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 29 Mar 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 development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women giving birth prematurely | – | Biological: Maternal blood sampling, Biological: Umbilical cord blood sampling, Biological: Placenta sampling, Other: Data collectionDelivery before 29 WA |
| Women giving birth at term | – | Biological: Maternal blood sampling, Biological: Umbilical cord blood sampling, Biological: Placenta samplingChildbirth between 39WA and 31WA+6 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Women giving birth at term or prematurely
Key inclusion criteria (4 listed)
- Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.
- Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.
- ≥18 years
- Mothers not under legal protection
Key exclusion criteria (4 listed)
- Mothers giving birth between 29WA and 38WA+6 days
- Mothers in critical condition.
- Person not affiliated to national health insurance
- For full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).
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 |
|---|---|---|
| Maternal blood sampling5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols | Biological | Women giving birth at term, Women giving birth prematurely |
| Umbilical cord blood sampling0.5mL sample from the umbilical cord after childbirth standard protocols | Biological | Women giving birth at term, Women giving birth prematurely |
| Placenta samplingSampling of 3 cotyledons by cutting across the thickness of the placenta | Biological | Women giving birth at term, Women giving birth prematurely |
| Data collectionNewborn, Maternal and Premature Retinopathy Screening Data Collection | Other | Women giving birth prematurely |
Primary outcome
Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery
Time frame: 16 weeks maximum after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 37803473Carre C, Acar N, Daruich A, Gregoire S, Martine L, Buteau B, Aho S, Eid P, Arnould L, Bron AM, Driessen M, Kermorvant E, Simon E, Creuzot-Garcher C, Gabrielle PH. Study protocol of OmegaROP-2 prospective study: expression of placental fatty acid receptors in preterm newborns with retinopathy of prematurity. BMC Ophthalmol. 2023 Oct 6;23(1):404. doi: 10.1186/s12886-023-03156-0.
- 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.
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 Prematurity and Retinopathy, 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 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: looking for participants now, as of the sponsor's last update on 22 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine CREUZOT-GARCHER (03.80.29.51.73, catherine.creuzot-garcher@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery (time frame: 16 weeks maximum after birth). 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 NCT04819893, 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 22 Sep 2025.