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Trial record 6 of 293 for:    retinopathy of prematurity

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02820662
Recruitment Status : Unknown
Verified June 2016 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Other: RETCAM Biological: Blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RETCAM Other: RETCAM
Biological: Blood samples

Primary Outcome Measures :
  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 Outcome Measures :
  1. Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes. [ Time Frame: At inclusion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02820662

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Contact: Philippe KOEHRER ext 33

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Centre Hospitalier Universitaire Recruiting
Dijon, France, 21079
Contact: Philippe KOEHRER    03 80 29 51 73 ext 33   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT02820662     History of Changes
Other Study ID Numbers: KOEHRER APJ 2014
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: July 1, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases