Lutein supplementation in very low birth weight (VLBW) neonates in neonatal intensive care units (NICU)
| ISRCTN | ISRCTN29971311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29971311 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/11/2009
- Registration date
- 23/11/2009
- Last edited
- 12/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paolo Manzoni
Scientific
Scientific
Neonatology and Hospital NICU
C. Spezia 60
Torino
10126
Italy
| paolomanzoni@hotmail.com |
Study information
| Study design | Multicentre prospective randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Lutein supplementation in VLBW neonates in NICU: a double-blind, multicentre, placebo-controlled, randomised trial |
| Study objectives | 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(s) | Approval received from the Ethical Committee of the Saint Anna Foundation (Fondazione Crescere insieme al SantAnna [ONLUS]), on behalf of each participating institution. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lutein/Zeaxanthin (LuteinOfta®) |
| Primary outcome measure | 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 study start date | 01/07/2008 |
| Completion date | 31/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 204 |
| Total final enrolment | 229 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 31/01/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
Neonatology and Hospital NICU
Torino
10126
Italy
10126
Italy
Sponsor information
Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)
Charity
Charity
Corso Spezia 60
Torino
10126
Italy
| d.farina@infinito.it | |
"ROR" |
https://ror.org/00k065b17 |
Funders
Funder type
Industry
Sooft Italia S.p.A. (Italy) (providing Lutein+ Zeaxanthyn and placebo, and financial support)
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? |
|---|---|---|---|---|---|
| Abstract results | 01/10/2009 | No | No | ||
| Results article | 01/01/2013 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
