Plain English Summary
Background and study aims
Retinopathy of prematurity is a disease that occurs in premature babies where abnormal blood vessels grow in the retina (the layer of nerve tissue in the eye). This growth can cause the retina to detach from the back of the eye, causing blindness. The aim of this study is to find out whether lutein and zeaxanthin supplements can prevent retinopathy of prematurity in preterm infants.
Who can participate?
Preterm infants (gestational age 32 weeks or less)
What does the study involve?
Participants are randomly allocated to receive a daily dose of lutein and zeaxanthin or a placebo (dummy drug) until discharged from hospital. The occurrence of retinopathy of prematurity is recorded in both groups to see whether the supplement prevents retinopathy of prematurity.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Careggi University Hospital of Florence (Italy)
When is the study starting and how long is it expected to run for?
February 2008 to February 2011
Who is funding the study?
SOOFT Italia S.p.a. (Italy)
Who is the main contact?
Prof. Carlo Dani
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01/2008
Study information
Scientific title
LUtein and zeaxanthin SUpplementation in Preterm infants to prevent RetinOpathy of Prematurity: a multicentre prospective randomised double-blind placebo-controlled study
Acronym
LUSUPROP Study
Study hypothesis
Retinopathy of prematurity (ROP) that was classified according to the International Classification as follows:
Stage 1, a thin demarcation line separates the avascular retina anteriorly from the vascularized retina posteriorly
Stage 2, a ridge arises in the region of the demarcation line and extends above the plane of the retina
Stage 3, neovascularization extends from the ridge into the vitreous
Stage 4, there is partial retinal detachment; stage 5, there is total retinal detachment
Moreover, increased venous dilation and arteriolar tortuosity are markers of severe active ROP and are referred to as plus disease.
Lutein and zeaxanthin supplementation may decrease the occurrence of retinopathy of prematurity (ROP) in high risk preterm infants.
Ethics approval
Ethics Committee for Clinical Trials of Medicines, University Hospital Careggi (Comitato Eitco per la sperimentazione clinica dei medicinali, Azienda ospedaliera Universitaria Careggi), 25/05/2007, ref: 38/2009
Study design
Multicentre prospective randomised double-blind placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Retinopathy of prematurity (ROP)
Intervention
Infants at each unit were grouped in blocks:
1. 1st block: gestational age < 25+6 weeks
2. 2nd block: gestational age from 26+0 to 28+6 weeks
3. 3rd block: gestational age > 29+0 weeks)
Infants were randomly assigned to a treatment group using the sealed envelope technique which were prepared at Careggi University Hospital of Florence and then distributed to participating centres. Each infant received a daily oral dose of 0.5 ml containing 0.14 mg of lutein and 0.006 mg of zeaxanthin (LUTEINofta®, Sooft Italia, Montegiorgio, Italy) or indistinguishable placebo. Supplementation was begun from the 1st to the 7th day of life and was given until discharge. Lutein/Zeaxanthin (L/Z) or placebo were given before feeding or added to breast milk (from the infant's mother or a donor) or to infant formula. Age and duration of supplementation were recorded. Time of initial feeding, use of breast milk or preterm infant formula, and change from preterm infant formula to term infant formula were at the discretion of the attending physician.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The successful rate of lutein and zeaxanthin supplementation at preventing ROP
2. The rate of primary endpoint was calculated on the basis of collected data and in agreement with those from literature, while the duration of follow up was decided on the basis of recommendation of the Italian Society of Neonatology and in agreement with the current literature
Secondary outcome measures
1. Gestational and post-natal age at ROP diagnosis
2. The need for surgical treatment (laser- or cryo-therapy)
3. The incidence of sepsis, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and mortality
Overall trial start date
01/02/2008
Overall trial end date
28/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Infants with gestational age < 32 weeks after parental informed consent
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
242
Participant exclusion criteria
1. The presence of major congenital malformation
2. Fetal hydrops
3. Death before the first ophthalmologic examination
3. Lack of lutein supplementation > 10 days during the first 30 days of life
4. Development of aggressive-posterior ROP (AP-ROP)
Recruitment start date
01/02/2008
Recruitment end date
28/02/2011
Locations
Countries of recruitment
Italy
Trial participating centre
Careggi University Hospital of Florence
Forence
50141
Italy
Funders
Funder type
Industry
Funder name
SOOFT Italia S.p.a. (Italy)
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
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22003960
Publication citations
-
Results
Dani C, Lori I, Favelli F, Frosini S, Messner H, Wanker P, De Marini S, Oretti C, Boldrini A, Massimiliano C, Bragetti P, Germini C, Lutein and zeaxanthin supplementation in preterm infants to prevent retinopathy of prematurity: a randomized controlled study., J. Matern. Fetal. Neonatal. Med., 2012, 25, 5, 523-527, doi: 10.3109/14767058.2011.629252.