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.

Обзор

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.

Вмешательства

• Биопрепарат Maternal blood sampling
  5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols
• Биопрепарат Umbilical cord blood sampling
  0.5mL sample from the umbilical cord after childbirth standard protocols
• Биопрепарат Placenta sampling
  Sampling of 3 cotyledons by cutting across the thickness of the placenta
• Другое Data collection
  Newborn, Maternal and Premature Retinopathy Screening Data Collection

Первичные конечные точки

• Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery [Срок оценки: 16 weeks maximum after birth]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 1 центр

• Chu Dijon Bourogne — Dijon

Публикации

• 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

Идентификаторы

NCT: NCT04819893 · CREUZOT-GARCHER 2020-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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