title: Lutein and zeaxanthin supplementation in preterm very low-birth-weight neonates in neonatal intensive care units: a multicenter randomized controlled trial.
abstract: BACKGROUND
  Human milk feeding protects against oxidative stress-induced damage in preterm neonates, including severe multifactorial diseases such as retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), and bronchopulmonary dysplasia (BPD). The carotenoids, which are not found in formula milk, might play a key role in these actions.
  
  
  METHODS
  A multicenter, double-blind, randomized controlled trial was conducted in three tertiary Italian neonatal intensive care units. All preterm infants < 32(+6) weeks' gestational age were eligible and were randomized to a single, oral, daily 0.5-mL dose of carotenoid supplementation (0.14 mg lutein + 0.0006 mg zeaxanthin) or placebo (5% glucose solution) from birth till 36 weeks' corrected gestational age. Primary outcomes were threshold ROP, NEC > second stage, and BPD. Surveillance for detection of these diseases and for intolerance/adverse effects was performed.
  
  
  RESULTS
  No treatment-related adverse effect was documented in the 229 analyzed infants, whose clinical/demographical characteristics were similar in the two groups. Threshold ROP incidence did not significantly differ in treated (6.2%) versus not treated infants (10.3%; p = 0.18). The same occurred for NEC (1.7% versus 5.1%; p = 0.15) and BPD (4.5% versus 10.3%; p = 0.07). Noteworthy, the progression rate from early ROP stages to threshold ROP was decreased by 50% (0.30 versus 0.44; p = 0.23).
  
  
  CONCLUSIONS
  Lutein/zeaxanthin supplementation in preterm infants is well tolerated. No significant effect was seen on threshold ROP, NEC, or BPD. The decreasing trends of these outcomes in the treatment group need to be assessed and confirmed on larger sample-sizes.
authors: Neonatology and NICU, S. Anna Hospital, Torino, Italy. paolomanzoni@hotmail.com
authors: Paolo
authors: P
authors: Manzoni
authors: Roberta
authors: R
authors: Guardione
authors: Paolo
authors: P
authors: Bonetti
authors: Claudio
authors: C
authors: Priolo
authors: Andrea
authors: A
authors: Maestri
authors: Caterina
authors: C
authors: Mansoldo
authors: Michael
authors: M
authors: Mostert
authors: Giovanni
authors: G
authors: Anselmetti
authors: Daniela
authors: D
authors: Sardei
authors: Massimo
authors: M
authors: Bellettato
authors: Paolo
authors: P
authors: Biban
authors: Daniele
authors: D
authors: Farina
mesh_terms: D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control*; D019587:Dietary Supplements; D018450:Disease Progression; D004311:Double-Blind Method; D020345:Enterocolitis, Necrotizing / Q000517:prevention & control*; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D015931:Intensive Care, Neonatal; D014975:Lutein / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D012178:Retinopathy of Prematurity / Q000517:prevention & control*; D024341:Xanthophylls / Q000009:adverse effects / Q000627:therapeutic use*; D065146:Zeaxanthins
chemical_list: D024341:Xanthophylls; D065146:Zeaxanthins; D014975:Lutein