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.

Recruiting

• Conditions: Prematurity; Retinopathy
• Interventions: Biological: Maternal blood sampling; Biological: Umbilical cord blood sampling; Biological: Placenta sampling; Other: Data collection

• Registration Number: NCT04819893
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-25
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Study Start: 2021-04-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women giving birth prematurely	Maternal blood sampling	Delivery before 29 WA
Women giving birth prematurely	Placenta sampling	Delivery before 29 WA
Women giving birth prematurely	Data collection	Delivery before 29 WA
Women giving birth prematurely	Umbilical cord blood sampling	Delivery before 29 WA
Women giving birth at term	Umbilical cord blood sampling	Childbirth between 39WA and 31WA+6 days
Women giving birth at term	Placenta sampling	Childbirth between 39WA and 31WA+6 days
Women giving birth at term	Maternal blood sampling	Childbirth between 39WA and 31WA+6 days

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France