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

Not Applicable

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Other: RETCAM; Biological: Blood samples

• Registration Number: NCT02820662
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-30
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Primary Completion: 2018-05-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-06
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RETCAM	RETCAM	-
RETCAM	Blood samples	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.	At inclusion

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Dijon, France