Trials / Recruiting
RecruitingNCT04819893
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.
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 135 (estimated)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Maternal blood sampling | 5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols |
| BIOLOGICAL | Umbilical cord blood sampling | 0.5mL sample from the umbilical cord after childbirth standard protocols |
| BIOLOGICAL | Placenta sampling | Sampling of 3 cotyledons by cutting across the thickness of the placenta |
| OTHER | Data collection | Newborn, Maternal and Premature Retinopathy Screening Data Collection |
Timeline
- Start date
- 2021-04-20
- Primary completion
- 2027-02-01
- Completion
- 2027-02-01
- First posted
- 2021-03-29
- Last updated
- 2025-09-22
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04819893. Inclusion in this directory is not an endorsement.