NCT04819893 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.
| NCT ID | NCT04819893 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Prematurity |
| Study Type | OBSERVATIONAL |
| Enrollment | 135 participants |
| Start Date | 2021-04-20 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 135 participants in total. It began in 2021-04-20 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
Inclusion Criteria: 1. Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition. 2. Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition. 3. ≥18 years 4. Mothers not under legal protection Exclusion Criteria: 1. Mothers giving birth between 29WA and 38WA+6 days 2. Mothers in critical condition. 3. Person not affiliated to national health insurance 4. 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04819893 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04819893 currently recruiting?
Yes, NCT04819893 is actively recruiting participants. Contact the research team at catherine.creuzot-garcher@chu-dijon.fr for enrollment information.
Where is the NCT04819893 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT04819893 clinical trial?
NCT04819893 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 135 participants.