Condition category
Eye Diseases
Date applied
12/05/2011
Date assigned
15/06/2011
Last edited
30/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 4

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carlo Dani

ORCID ID

Contact details

Division of Neonatology
Careggi University Hospital of Florence
Largo Brambilla 3
Forence
50141
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01/2008

Study information

Scientific title

LUtein and zeaxanthin SUupplementation 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, Florence, Italy (Comitato Eitco per la sperimentazione clinica dei medicinali, Azienda ospedaliera Universitaria Careggi, Firenze) approved on 25th May 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 below to request a patient information sheet

Condition

Retinopathy of prematurity (ROP)

Intervention

1. Infants at each unit were grouped in blocks
1.1. 1st block: gestational age < 25+6 weeks
1.2. 2nd block: gestational age from 26+0 to 28+6 weeks
1.3. 3rd block: gestational age > 29+0 weeks)
2. 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
3. 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
4. Supplementation was begun from the 1st to the 7th day of life and was given until discharge
5. 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
6. Age and duration of supplementation were recorded
7. 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. Evaluate the successful rate of lutein and zeaxanthin supplementation in preventing ROP
2. The rate of primary endpoint was calculated on the basis of data collected in our centers 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. The evaluation of gestational and post-natal age at ROP diagnosis
2. The need for surgical treatment (laser- or cryo-therapy)
3. The comparison of the incidence of sepsis, intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) and mortality in the two groups

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

Division of Neonatology
Forence
50141
Italy

Sponsor information

Organisation

University of Florence (Italy)

Sponsor details

Department of Surgical and Medical Critical Care
Viale Morgagni 85
Florence
50141
Italy

Sponsor type

University/education

Website

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22003960

Publication citations

  1. 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.

Additional files

Editorial Notes