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

N/ACompletedNCT02820662

Centre Hospitalier Universitaire Dijon62 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Retinopathy of Prematurity

Interventions

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 4 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005.

Time frame: At 4 weeks of life or 31 weeks of amenorrhea

Secondary Outcomes

Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.

Time frame: At inclusion