title: Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants.
abstract: BACKGROUND
  Preterm infants are at risk for adverse neurodevelopment. Furthermore, nutrition may play a key role in supporting neurodevelopment. The aim of this study was to evaluate whether a nutrient-enriched formula fed to preterm infants after hospital discharge could improve their neurodevelopment at 24 months (term-corrected age).
  
  
  METHODS
  We conducted an observer-blinded, single-center, randomized controlled trial in infants admitted to the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Italy between 2009 and 2011. Inclusion criteria were gestational age < 32 weeks and/or birth weight < 1500 g, and being fed human milk for < 20% of the total milk intake. Exclusion criteria were congenital malformations or conditions that could interfere with growth or body composition. Included infants were randomized to receive a standard full-term formula or a nutrient-enriched formula up until 6 months of corrected age, using two computer-generated randomization lists; one appropriate for gestational age (AGA) and one for small for gestational age (SGA) infants. We assessed neurodevelopment at 24 months of corrected age using the Griffiths Mental Development Scale and related subscales (locomotor, personal-social, hearing and speech, hand and eye coordination, and performance).
  
  
  RESULTS
  Of the 207 randomized infants, 181 completed the study. 52 AGA and 35 SGA infants were fed a nutrient-enriched formula, whereas 56 AGA and 38 SGA infants were fed a standard full-term formula. The general quotient at 24 months of corrected age was not significantly different between infants randomized to receive a nutrient-enriched formula compared with a standard term formula up until 6 months of corrected age (AGA infants: 93.8 ± 12.6 vs. 92.4 ± 10.4, respectively; SGA infants: 96.1 ± 9.9 vs. 98.2 ± 9, respectively). The scores of related subscales were also similar among groups.
  
  
  CONCLUSIONS
  This study found that feeding preterm infants a nutrient-enriched formula after discharge does not affect neurodevelopment at 24 months of corrected age, in either AGA or SGA infants, free from major comorbidities.
  
  
  BACKGROUND
  Current Controlled Trials (http://www.controlled-trials.com/ISRCTN30189842) London, UK.
authors.affiliation: NICU, Department of Clinical Sciences and Community Health, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Via Commenda 12, 20122 Milano, Italy. maria.gianni@unimi.it.
authors.forename: Maria Lorella
authors.initials: ML
authors.lastname: Giannì
authors.forename: Paola
authors.initials: P
authors.lastname: Roggero
authors.forename: Orsola
authors.initials: O
authors.lastname: Amato
authors.forename: Odoardo
authors.initials: O
authors.lastname: Picciolini
authors.forename: Pasqua
authors.initials: P
authors.lastname: Piemontese
authors.forename: Nadia
authors.initials: N
authors.lastname: Liotto
authors.forename: Francesca
authors.initials: F
authors.lastname: Taroni
authors.forename: Fabio
authors.initials: F
authors.lastname: Mosca
mesh_terms: D001921:Brain / Q000254:growth & development*; D002657:Child Development; D002675:Child, Preschool; D005260:Female; D005527:Food, Fortified; D006801:Humans; D041943:Infant Formula; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D011446:Prospective Studies; D016037:Single-Blind Method