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Completed

NCT Number: NCT02820662

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

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).

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

0 month–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RETCAM

Other

blood samples

Biological

Primary outcomes

  1. 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

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

    Time frame: At inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns

Acronym: OMEGAROP

Important dates

Study start
2015
Primary completion
2018
First posted
Jul 1, 2016
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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