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NCT Number: NCT04819893

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.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Chloé Carré

CONTACT

[email protected]

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Maternal blood sampling

Biological

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

Umbilical cord blood sampling

Biological

0.5mL sample from the umbilical cord after childbirth standard protocols

Placenta sampling

Biological

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

Data Collection

Other

Newborn, Maternal and Premature Retinopathy Screening Data Collection

Primary outcomes

  1. Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery

    Time frame: 16 weeks maximum after birth

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine CREUZOT-GARCHER

CONTACT

[email protected]

03.80.29.51.73

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: OMEGAROP 2

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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