CompletedPhase 1/2

Evaluation of Antioxidant Activity of Oral Lutein in Preterm and Term Newborn

Italy100 participantsStarted 2011-01

Plain-language summary

The balance of the redox state is important for normal embryonic and fetal development . During the perinatal period, a variety of conditions are responsible for an excessive production of free radicals. The following oxidative stress is exacerbated by a lack of antioxidant substances that have not yet matured. At the moment there are no therapeutic strategies with single or combined antioxidants that have been shown to be clinically effective. Breastfeeding is important for the contribution of the antioxidant defenses of the newborn and the nutritional status of the mother plays a key role because it influences the nutritional status of the newborn. Lutein is a carotenoid that is not produced by the body , but taken with food or supplements. The molecule carries out different activities : antioxidant, anti-inflammatory, anticancer , neuroprotective. Its main activity of inhibition of peroxidation of membrane lipids is peculiarly important for the photoreceptors and neurons whose membranes are rich with polyunsaturated fatty acids. Current evidence on its role as an antioxidant indicate that supplementation with lutein may play a significant role in the prevention of free radical disease in the newborn

Who can participate

Age range

1 Minute – 5 Minutes

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * healthy singleton term newborns discharged on third day of life whose mothers had low-obstetric risk and with normal adaptation to extrauterine life Exclusion Criteria: The exclusion criteria included newborns with severe malformations, suffering from perinatal hypoxia or born to mothers with mental disorders

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Antioxidant status in the newborns

Timeframe: First days of life

Trial details

NCT IDNCT02068807

SponsorUniversity of Siena

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-01

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