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. (OMEGAROP 2)

February 16, 2024 updated by: Centre Hospitalier Universitaire Dijon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women giving birth at term or prematurely

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women giving birth prematurely
Delivery before 29 WA
Biological: Maternal blood sampling
5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols
Biological: Umbilical cord blood sampling
0.5mL sample from the umbilical cord after childbirth standard protocols
Biological: 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
Women giving birth at term
Childbirth between 39WA and 31WA+6 days
Biological: Maternal blood sampling
5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols
Biological: Umbilical cord blood sampling
0.5mL sample from the umbilical cord after childbirth standard protocols
Biological: Placenta sampling
Sampling of 3 cotyledons by cutting across the thickness of the placenta

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2021

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

March 25, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREUZOT-GARCHER 2020-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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