Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born Infants
OMEGAROP
1 other identifier
interventional
62
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2015
CompletedFirst Submitted
Initial submission to the registry
June 29, 2016
CompletedFirst Posted
Study publicly available on registry
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedFebruary 6, 2026
February 1, 2026
2.8 years
June 29, 2016
February 4, 2026
Conditions
Outcome Measures
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.
At 4 weeks of life or 31 weeks of amenorrhea
Secondary Outcomes (1)
Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.
At inclusion
Study Arms (1)
RETCAM
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire
Dijon, 21079, France
Related Publications (1)
Pallot C, Soudry Faure A, Charvy C, Ternoy N, Langlet Muteau C, Acar N, Bron AM, Speeg Schatz C, Creuzot-Garcher C. Screening for Retinopathy of Prematurity: Insight into Optimizing Screening. Ophthalmic Res. 2018;59(4):228-234. doi: 10.1159/000477622. Epub 2017 Jul 27.
PMID: 28746942RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2016
First Posted
July 1, 2016
Study Start
July 30, 2015
Primary Completion
May 31, 2018
Last Updated
February 6, 2026
Record last verified: 2026-02