Condition category
Pregnancy and Childbirth
Date applied
15/11/2009
Date assigned
23/11/2009
Last edited
23/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 disease’s 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 Sant’Anna [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.

Publication citations

Additional files

Editorial Notes