Status:
WITHDRAWN
Early Administration of the Lutein/Zeaxanthin in Premature Newborns
Lead Sponsor:
Sooft Italia
Collaborating Sponsors:
Fondazione Poliambulanza Istituto Ospedaliero
University of Siena
Conditions:
Antioxidant Role of the Lutein in Preterm Newborn
Eligibility:
All Genders
24-32 years
Phase:
NA
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 ...
Detailed Description
Lutein is the most important carotenoid present selectively in certain tissues of the human body, mainly at the level of the retina, macula (hence the name) and lens. In tissues and serum, lutein is f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03340103
Start Date
October 11 2018
End Date
October 11 2019
Last Update
November 2 2020
Active Locations (4)
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1
Azienda Ospedaliera Universitaria Padova
Padua, Italia, Italy, 35128
2
Azienda Ospedaliera Le Scotte Siena
Siena, Italia, Italy, 53100
3
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
4
University Hospital Perugia
Perugia, Italy, 06121-06135