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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04819893

Acronym

OMEGAROP 2

Enrollment

135

Registered

2021-03-29

Start date

2021-04-20

Completion date

2027-02-28

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, Retinopathy

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.

Interventions

BIOLOGICALMaternal blood sampling

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

BIOLOGICALUmbilical cord blood sampling

0.5mL sample from the umbilical cord after childbirth standard protocols

BIOLOGICALPlacenta sampling

Sampling of 3 cotyledons by cutting across the thickness of the placenta

OTHERData collection

Newborn, Maternal and Premature Retinopathy Screening Data Collection

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery	16 weeks maximum after birth

Countries

France

Contacts

Primary ContactCatherine CREUZOT-GARCHER

catherine.creuzot-garcher@chu-dijon.fr03.80.29.51.73

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026