Early Administration of the Lutein/Zeaxanthin in Premature Newborns

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.

Conditions

• Antioxidant Role of the Lutein in Preterm Newborn

Interventions

DIETARY_SUPPLEMENT

LUTEIN ofta 0,5 gocce

LUTEIN ofta 0,5 gocce, containing a solution of 5% Lutein and 2,5% Zeaxanthin with excipients (Corn starch, glucose, potassium sorbate, xanthan gum, citric acid)

DRUG

Placebo

Placebo solution with unique excipients (Demineralised water, potassium sorbate, xanthan gum, citric acid)

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero

  collaborator OTHER

• University of Siena

  collaborator OTHER

• University Hospital Padova

  collaborator OTHER

• University Hospital Perugia

  collaborator UNKNOWN

• Sooft Italia

  lead INDUSTRY

Principal Investigators

• Sara Magnanelli, M.D. · Sooft Italia

• Giuseppe De Bernardo, M.D. · Sooft Italia

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

24 Weeks

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-11

Primary Completion

2019-10-11

Completion

2019-10-11

Countries

• Italy

Study Locations