Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born Infants (OMEGAROP)

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Biological: Blood samples; Other: RETCAM

Study type: Interventional

Funder types: Other

Identifiers

NCT02820662

KOEHRER APJ 2014

Details and patient eligibility

About

The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).

Enrollment: 62 patients

Sex: All

Ages: Under 4 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant

Exclusion criteria

• Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

RETCAM

Experimental group

Treatment:

Other: RETCAM

Biological: Blood samples