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.

NCT ID: NCT04819893

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-20

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Prematurity Retinopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women giving birth prematurely

Delivery before 29 WA

Maternal blood sampling

Intervention Type BIOLOGICAL

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

Umbilical cord blood sampling

Intervention Type BIOLOGICAL

0.5mL sample from the umbilical cord after childbirth standard protocols

Placenta sampling

Intervention Type BIOLOGICAL

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

Data collection

Intervention Type OTHER

Newborn, Maternal and Premature Retinopathy Screening Data Collection

Women giving birth at term

Childbirth between 39WA and 31WA+6 days

Maternal blood sampling

Intervention Type BIOLOGICAL

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

Umbilical cord blood sampling

Intervention Type BIOLOGICAL

0.5mL sample from the umbilical cord after childbirth standard protocols

Placenta sampling

Intervention Type BIOLOGICAL

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

Interventions

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Maternal blood sampling

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

Intervention Type BIOLOGICAL

Umbilical cord blood sampling

0.5mL sample from the umbilical cord after childbirth standard protocols

Intervention Type BIOLOGICAL

Placenta sampling

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

Intervention Type BIOLOGICAL

Data collection

Newborn, Maternal and Premature Retinopathy Screening Data Collection

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Catherine CREUZOT-GARCHER

Role: CONTACT

03.80.29.51.73

Facility Contacts

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Chloé Carré

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37803473 (View on PubMed)

Other Identifiers

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CREUZOT-GARCHER 2020-1

Identifier Type: -

Identifier Source: org_study_id

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