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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maternal blood sampling, Umbilical cord blood sampling, Placenta sampling, Data collection.
- Who it may be relevant to
- Registry conditions: Prematurity, Retinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery [Time frame: 16 weeks maximum after birth]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Chu Dijon Bourogne — Dijon
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. PMID 37803473
Identifiers
NCT: NCT04819893 · CREUZOT-GARCHER 2020-1