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

Primary Purpose

Retinopathy of Prematurity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

RETCAM

Blood samples

About this trial

This is an interventional other trial for Retinopathy of Prematurity

Eligibility Criteria

undefined - 4 Months (Child)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RETCAM

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02820662

First Posted

June 29, 2016

Last Updated

May 6, 2019

Sponsor

Centre Hospitalier Universitaire Dijon

1. Study Identification

Unique Protocol Identification Number

NCT02820662

Brief Title

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

Acronym

OMEGAROP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

July 30, 2015 (Actual)

Primary Completion Date

May 31, 2018 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Dijon

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinopathy of Prematurity

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RETCAM

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

RETCAM

Intervention Type

Biological

Intervention Name(s)

Blood samples

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Time Frame

At inclusion

10. Eligibility

Sex

All

Maximum Age & Unit of Time

4 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Centre Hospitalier Universitaire

City

Dijon

ZIP/Postal Code

21079

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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