Lutein supplementation in very low birth weight (VLBW) neonates in neonatal intensive care units (NICU)

Lutein supplementation in VLBW neonates in NICU: a double-blind, multicentre, placebo-controlled, randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29971311

Enrollment

204

Registered

2009-11-23

Start date

2008-07-01

Completion date

Unknown

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorders of preterm very low birth weight infants Pregnancy and Childbirth

Interventions

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 g

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026