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Early Administration of the Lutein/Zeaxanthin in Premature Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03340103
Recruitment Status : Unknown
Verified November 2017 by Sooft Italia.
Recruitment status was:  Recruiting
First Posted : November 13, 2017
Last Update Posted : November 14, 2017
Sponsor:
Collaborators:
Azienda Ospedaliera di Rilievo Nazionale Santobono-Pausilipon
University of Siena
University Hospital Padova
Academic Emergency County Hospital Sibiu
Information provided by (Responsible Party):
Sooft Italia

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.

Condition or disease Intervention/treatment Phase
Antioxidant Role of the Lutein in Preterm Newborn Dietary Supplement: LUTEIN ofta 0,5 gocce Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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)

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Evaluation of the Antioxidant Activity of Lutein/Zeaxanthin Early Administered to Premature Newborns
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Lutein

Arm Intervention/treatment
Experimental: Experimental group A
Group A (25 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
LUTEIN ofta 0,5 gocce, containing a solution of 5% Lutein and 2,25% Zeaxanthin with excipients (Corn starch, glucose, potassium sorbate, xanthan gum, citric acid)

Placebo Comparator: Control group B
Group B (25 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
Placebo solution with unique excipients (Demineralised water, potassium sorbate, xanthan gum, citric acid)




Primary Outcome Measures :
  1. Change of the lutein's antioxidant power, after early oral administration in premature newborns [ Time Frame: 0 day - 15 days - 30 days ]
    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

  2. Change of the premature newborns' oxidative stress, after early oral administration of the lutein [ Time Frame: 0 day - 15 days - 30 days ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340103


Contacts
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Contact: Giuseppe De Bernardo, M.D. +393357441303 pinodebtin@gmail.com
Contact: Giuseppe Buonocore, Prof. +393491770396 buonocore@unisi.it

Locations
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Italy
Azienda Ospedaliera di Rilievo Nazionale Santobono-Pausilipon Recruiting
Napoli, Italia, Italy, 80100
Contact: Giuseppe De Bernardo, M.D.    +393357441303    pinodebtin@gmail.com   
Contact: Desiree Sordino, M.D.    +393383482584    dsordino@gmail.com   
Principal Investigator: Giuseppe De Bernardo, M.D.         
Azienda Ospedaliera Universitaria Padova Recruiting
Padova, Italia, Italy, 35128
Contact: Daniele Trevisanuto, Prof.    +393406632734    daniele.trevisanuto@gmail.com   
Sub-Investigator: Daniele Trevisanuto, Prof.         
Azienda Ospedaliera Le Scotte Siena Recruiting
Siena, Italia, Italy, 53100
Contact: Giuseppe Buonocore, Prof.    +393491770396    buonocore@unisi.it   
Sub-Investigator: Giuseppe Buonocore, Prof.         
Sub-Investigator: Mariangela Longini, Dr.         
Sponsors and Collaborators
Sooft Italia
Azienda Ospedaliera di Rilievo Nazionale Santobono-Pausilipon
University of Siena
University Hospital Padova
Academic Emergency County Hospital Sibiu
Investigators
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Study Chair: Sara Magnanelli, M.D. Sooft Italia
Principal Investigator: Giuseppe De Bernardo, M.D. Sooft Italia
  Study Documents (Full-Text)

Documents provided by Sooft Italia:
Informed Consent Form  [PDF] June 9, 2017

Publications of Results:
Giuseppe Buonocore, Monica Tei, Serafina Perrone. Lutein as protective agent against neonatal oxidative stress. Journal of Pediatric and Neonatal Individualized Medicine 2014;3(2):e030244.
Fanaris, Bel BO, Guidettic E et al. Ruolo della Luteina nella prevenzione delle patologie oculari nel neonato. Rivista Italiana di Medicina Pediatrica 2006;numero speciale:51-53
Yanoff M and Duker i.S (2005) "Ophthalmology" Edizione italiana ed 2003 ristampa 2005, Antonio Delfino Editore medicina-scienze, volume 1, cap 1.3
Jackson JG, Eric L, Lien A, Sharon J, White B, Nicholas J, Bruns C, Charles F, Kuhlman A. Major carotenoids in mature human milk: longitudinal and diurnal patterns. The Journal of Nutritional Biochemistry 1998 Jan;9(1):2-7.

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Responsible Party: Sooft Italia
ClinicalTrials.gov Identifier: NCT03340103    
Other Study ID Numbers: 425 9/6/2017
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sooft Italia:
Lutein/Zeaxanthin
Antioxidant
Oxidative stress
Carotenoid
Preterm newborn
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications