Early Administration of the Lutein/Zeaxanthin in Premature Newborns

• Status: Withdrawn
• Trial end date: 2019-10-11
• Target enrollment: 0
• Participant gender: All

Summary

Premature birth is the most common cause of mortality, morbidity and disability. Premature infants have a higher risk of developing damage in the eyes (retinopathy of prematurity ROP), in the central nervous system (intraventricular hemorrhage IVH), in the lungs (bronchial pulmonary dysplasia BPD), in the gut (NEC) and infections. Oxidative stress has been implicated in various capacities, in the etiology of these conditions. Lutein and Zeaxanthin are powerful anti-oxidants and commonly assimilated with different foods. Lutein and Zeaxanthin are present at level of umbilical cord, in the breast milk (particularly in colostrum) and pass the placental barrier. Concerning supplementations, the lutein presents, for its specific characteristics, a high bioavailability after oral administration. In the last few years, there have been more and more studies which have shown that lutein could constitute a valid and important preventive and protective factor against certain diseases related to oxidative stress. The preparations of lutein and zeaxanthin have never pointed out in the human being (included in the term newborn) adverse or toxic effects. This spontaneous / non-commercial pilot study involves the administration of a dietary supplement containing lutein / zeaxanthin, because the healthcare structures need to identify a natural antioxidant product that can reduce the incidence of serious diseases related to oxidative stress in the perinatal period. This study aims to evaluate if the administration of lutein in watery solution will reduce the rate of free radicals in preterm infants.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sooft Italia
• Collaborators: Academic Emergency County Hospital Sibiu; Azienda Ospedaliera di Rilievo Nazionale Santobono-Pausilipon; Fondazione Poliambulanza Istituto Ospedaliero; University Hospital Padova; University Hospital Perugia; University of Siena
• Treatments: Antioxidants

Criteria

Inclusion Criteria:

• Newborns with a body weight at birth ≤ 1.500 grams and/or gestational age ≤ 32 weeks

• Male and female newborns

• Newborns whose parents want to sign the informed consent

• Informed consent

Exclusion Criteria:

• Informed consent is not signed

• Infants with a body weight at birth ≥ 1.500 gramms and/or gestational age > 32 weeks

• Infants hospitalized after 36 hours of life

• Infants with Ophthalmologic diseases

• Infants with severe malformations