Lutein and zeaxanthin supplementation in preterm infants to prevent retinopathy of prematurity
| ISRCTN | ISRCTN10624844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10624844 |
| Secondary identifying numbers | 01/2008 |
- Submission date
- 12/05/2011
- Registration date
- 15/06/2011
- Last edited
- 23/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
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
Contact information
Scientific
Division of Neonatology
Careggi University Hospital of Florence
Largo Brambilla 3
Forence
50141
Italy
Study information
| Study design | Multicentre prospective randomised double-blind placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | LUtein and zeaxanthin SUpplementation in Preterm infants to prevent RetinOpathy of Prematurity: a multicentre prospective randomised double-blind placebo-controlled study |
| Study acronym | LUSUPROP Study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/02/2008 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 242 |
| Key inclusion criteria | Infants with gestational age < 32 weeks after parental informed consent |
| Key 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) |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Italy
Study participating centre
50141
Italy
Sponsor information
University/education
Department of Surgical and Medical Critical Care
Viale Morgagni 85
Florence
50141
Italy
"ROR" |
https://ror.org/04jr1s763 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2012 | Yes | No |
Editorial Notes
23/05/2017: Plain English summary added.
