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.

Prematurity Clinical Trial

— OMEGAROP 2  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04819893
• Other study ID #: CREUZOT-GARCHER 2020-1
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Catherine CREUZOT-GARCHER
• Phone: 03.80.29.51.73
• Email: catherine.creuzot-garcher[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Premature Birth
• Prematurity
• Retinal Diseases
• Retinopathy
• Retinopathy of Prematurity

Intervention

Biological:
• Maternal blood sampling
5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols
• Umbilical cord blood sampling
0.5mL sample from the umbilical cord after childbirth standard protocols
• Placenta sampling
Sampling of 3 cotyledons by cutting across the thickness of the placenta

Other:
• Data collection
Newborn, Maternal and Premature Retinopathy Screening Data Collection

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

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