Early Administration of the Lutein/Zeaxanthin in Premature Newborns

NCT03340103 | Withdrawn DMC

• 1 other identifier: 3172 10/10/2018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Lutein/Zeaxanthin; Antioxidant; Oxidative stress; Carotenoid; Preterm newborn

Outcome Measures

Primary Outcomes (2)

• Change of the lutein's antioxidant power, after early oral administration in premature newborns

  Biological antioxidant potential (micromol/L) will be analyzed as marker of the antioxidant power. This marker will be tested at birth (0 day) by blood sampling from umbilical vein, while at 15 days and 30 days by peripheral blood

  0 day - 15 days - 30 days

• Change of the premature newborns' oxidative stress, after early oral administration of the lutein

  Total hydroperoxide (Ucarr) will be analyzed as marker of the oxidative stress. This marker will be tested at birth (0 day) by blood sampling from umbilical vein, while at 15 days and 30 days by peripheral blood

  0 day - 15 days - 30 days

Study Arms (2)

Experimental group A

EXPERIMENTAL

Group A (18 newborns) will be treated with LUTEIN ofta 0,5 drops, (1 ml per Kg equal to 0,5 mg of lutein and 0,05 of zeaxantin) additionaly to the standard hospital treatment foreseen. The first dose will be given within 36 hours of life, the least to 30th day of life.

Dietary Supplement: LUTEIN ofta 0,5 gocce

Control group B

PLACEBO COMPARATOR

Group B (18 newborns) treated with Placebo solution additionaly to the standard hospital treatment foreseen. The first dose will be given within 36 hours of life, the least to 30th day of life.

Drug: Placebo

Interventions

LUTEIN ofta 0,5 gocce DIETARY_SUPPLEMENT

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)

Experimental group A

Placebo DRUG

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

Control group B

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sooft Italia: lead
• Fondazione Poliambulanza Istituto Ospedaliero: collaborator
• University of Siena: collaborator
• University Hospital Padova: collaborator
• University Hospital Perugia: collaborator

Study Sites (4)

Azienda Ospedaliera Universitaria Padova

Padua, Italia, 35128, Italy

Location

Azienda Ospedaliera Le Scotte Siena

Siena, Italia, 53100, Italy

Location

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

University Hospital Perugia

Perugia, 06121-06135, Italy

Location

Related Publications (56)

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  RESULT

Study Officials

• Sara Magnanelli, M.D.

  Sooft Italia

  STUDY CHAIR

• Giuseppe De Bernardo, M.D.

  Sooft Italia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Pilot study, non-commercial, with food supplement, treated vs. control with a ratio 1: 1 double-blind. The identical vials, corresponding to placebo and active product, have an alphanumeric code without meaning for the operator, but that identifies the treaties from controls, in an anonymous document kept by the Statistical. The document will be placed in a sealed and anonymous envelope and it will be kept open by the statistician at the time of data analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Since birth, premature newborns, that are comply with the inclusion parameters, will be introduced and separated in two random groups (A and B). All newborns, during the observation period, will be submitted to the blood collection (1 ml) from the umbilical cord and peripheral site (at the same time with the routine collections) on which there will be performed blood gas analysis and oxidative stress markers (TH and BAP)

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 13, 2017
• Study Start: October 11, 2018
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)