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Clinical Trials in France / NCT04819893
Recruiting Observational

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.

NCT04819893 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire Dijon
Phase
Observational
Started
2021-04-20
Last updated
2025-09-22

Condition(s) studied

PrematurityRetinopathy

Investigational drug(s) / intervention(s)

Maternal blood samplingUmbilical cord blood sampling →Placenta sampling →Data collection

Maternal blood sampling: 5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols

Umbilical cord blood sampling: 0.5mL sample from the umbilical cord after childbirth standard protocols

Placenta sampling: Sampling of 3 cotyledons by cutting across the thickness of the placenta

Data collection: Newborn, Maternal and Premature Retinopathy Screening Data Collection

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chu Dijon Bourogne Dijon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04819893 on ClinicalTrials.gov ↗ ← All trials in France