Can supplementation with Omega-3 fatty acids in preterm infants improve visual and cognitive outcome?

• Conditions: Premature male/female infants, <28 gestational weeks at birth with risk of developing retinopathy of prematurity (ROP); Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2008-000046-31-SE
• Lead Sponsor: The Sahlgrenska Center for Pediatric Ophtalmology Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-11
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must meet all the following inclusion criteria to be permitted into this study:
1.Signed informed consent from parents/guardians;
2.Subject must be <28 weeks of gestation

Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will be excluded from the study:
1.Detectable clinical gross malformation;
2.Known or suspected chromosomal abnormality, genetic disorder, or syn-drome, according to the investigator’s opinion;

3.Clinically significant neuropathy, nephropathy, retinopathy, or other micro- or macrovascular disease requiring treatment, according to the investigator’s opinion;
4.Any other condition or therapy that, in the investigator’s opinion, may pose a risk to the subject or interfere with the subject’s ability to be compliant with this protocol or interfere with interpretation of results;
5.Bleeding disorder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified