Contact information
Type
Scientific
Primary contact
Dr Paolo Manzoni
ORCID ID
Contact details
Neonatology and Hospital NICU
C. Spezia 60
Torino
10126
Italy
paolomanzoni@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Lutein supplementation in VLBW neonates in NICU: a double-blind, multicentre, placebo-controlled, randomised trial
Acronym
Study hypothesis
To evaluate the efficacy of Lutein and Zeaxanthin supplementation in the prevention of Retinopathy of Prematurity (Rop), Bronchopulomonary dysplasia (BPD), Necrotising Enterocolitis (NEC) in preterm very low birth weight (i.e., <1500g at birth) infants in NICU.
Human milk feedings of preterm infants have been associated with a lower incidence of retinopathy of prematurity (ROP), a disorder affecting the retinal vessels that may lead to blindness. The carotenoids in human milk (lutein, b-carotene, zeaxanthin, lycopene) may provide the highest protection against both light-induced and metabolic oxidative damage in the retina and in other developing tissues. Carotenoids are a family of polyene, lipophilic molecules found in human milk but not in formulas and are preferentially accumulated in the eyes. Carotenoids such as Lutein and Zeaxanthyn, due to their anti-oxydative properties, might be also active in prevention of a number of multifactorial diseases related to prematurity, in which an oxidative insult is crucial for the diseases onset. The aim of this study is thus to evaluate the relation of carotenoids with the development of ROP, BPD, NEC in human milk fed preterm infants.
Ethics approval
Approval received from the Ethical Committee of the Saint Anna Foundation (Fondazione Crescere insieme al SantAnna [ONLUS]), on behalf of each participating institution.
Study design
Multicentre prospective randomised double blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Disorders of preterm very low birth weight infants
Intervention
1. The regimens in the two intervention groups will be :
Group A: Lutein/Zeaxanthin supplementation (14 drops, i.e. 0.5 ml, meaning 0.14 mg of Lutein and 0.0006 mg of Zeaxanthin; LuteinOfta® gtt, NEOOX Division of SOOFT Italia s.p.a., Montegiorgio, Italy; Group A)
Group B: placebo (0.5 ml of a 5% glucose solution) .
2. Drug and placebo will be administered in a single oral daily dose from birth till the 36th week of gestational age (corrected age).
3. Administration will start within the first 48 h of life
4. Neonates not feeding in the first 48 hours will receive the drug/placebo by oral/naso-gastric tube and can be enrolled in the absence of gastric instability and/or repeated gastric residuals or vomit.
5. If they repeatedly display gastric instability, gastric residuals or vomit, they may be enrolled at any point during the first week of life, depending on the first "efficacious" feedings. The day of life in which they first received the drugs/placebo is started will be recorded in the database, and their statistics will be limited to the days of administration exposure to intervention.
Intervention type
Drug
Phase
Not Specified
Drug names
Lutein/Zeaxanthin (LuteinOfta®)
Primary outcome measures
The primary objective of the study will be to evaluate the effectiveness of Lutein with Zeaxanthin compared to placebo in the prevention of ROP of any stage, BPD, and NEC of surgical stage (i.e., 2nd or greater according to Bell classification) in the preterm neonates <32+6 wks g.a. admitted to the participant NICUs. Surveillance for detection of these diseases, as well as for intolerance/adverse effects will be performed till discharge. Measurements of serum liver enzymes values will be also performed at 4 wks of age.
Secondary outcome measures
1. Assessment of the incidence of NEC of all stages
2. Intestinal perforation
3. Late-onset sepsis
4. Mortality prior to discharge
5. Death or NEC (all stages)
6. Death or sepsis or NEC (surgical stage)
7. Severe (grade 3-4) intraventricular haemorrhage
8. Liver failure
Overall trial start date
01/07/2008
Overall trial end date
31/01/2010
Reason abandoned
Eligibility
Participant inclusion criteria
All neonates with gestational age (g.a.) less than 32 wks + 6 days (i.e., all those qualifying for screening of ROP) born within the study period, whether at one of the participant Institutions or elsewhere, were eligible for the study.
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
204
Participant exclusion criteria
1. Parental refusal
2. Admission after 48 hours of life
3. Death prior to 72 hours of life
4. Ophtalmological disease already present at the time of randomisation
Recruitment start date
01/07/2008
Recruitment end date
31/01/2010
Locations
Countries of recruitment
Italy
Trial participating centre
Neonatology and Hospital NICU
Torino
10126
Italy
Sponsor information
Organisation
Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)
Sponsor details
Corso Spezia 60
Torino
10126
Italy
d.farina@infinito.it
Sponsor type
Charity
Website
Funders
Funder type
Industry
Funder name
Sooft Italia S.p.A. (Italy) (providing Lutein+ Zeaxanthyn and placebo, and financial support)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Paolo Manzoni, Roberta Guardione, Paolo Bonetti, Claudio Priolo, Andrea Maestri, Mansoldo Caterina, Paolo Biban, Giovanni Anselmetti, Daniele Farina
Lutein and zeaxanthin supplementation in preterm infants in NICU: Preliminary data from a multicentre RCT
Early Hum Dev. 2009 Oct;85(10 Suppl):S93-S94.