OMEGAROP 2: 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.

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT04819893
Collaborator
(none)
100
1
21.4
4.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Maternal blood sampling
  • Biological: Umbilical cord blood sampling
  • Biological: Placenta sampling
  • Other: Data collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Actual Study Start Date :
Apr 20, 2021
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery [16 weeks maximum after birth]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chu Dijon Bourogne Dijon France 21000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT04819893
Other Study ID Numbers:
  • CREUZOT-GARCHER 2020-1
First Posted:
Mar 29, 2021
Last Update Posted:
Sep 5, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021