Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants

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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.Trial registration: Current Controlled Trials (http://www.controlled-trials.com/ISRCTN30189842) London, UK.

Original languageEnglish
Article number74
JournalBMC Pediatrics
Volume14
Issue number1
DOIs
Publication statusPublished - Mar 19 2014

Fingerprint

Small for Gestational Age Infant
Premature Infants
Gestational Age
Food
Human Milk
Random Allocation
Body Composition
Birth Weight
Italy
Hearing
Comorbidity
Milk
Randomized Controlled Trials
Hand
Growth

Keywords

  • Neurodevelopment
  • Nutrient-enriched formula
  • Post discharge nutrition
  • Preterm infants

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

@article{4d0f355913ff4738b9742958fc826d95,
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 C{\`a} 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.Trial registration: Current Controlled Trials (http://www.controlled-trials.com/ISRCTN30189842) London, UK.",
keywords = "Neurodevelopment, Nutrient-enriched formula, Post discharge nutrition, Preterm infants",
author = "Giann{\`i}, {Maria L.} and Paola Roggero and Orsola Amato and Odoardo Picciolini and Pasqua Piemontese and Nadia Liotto and Francesca Taroni and Fabio Mosca",
year = "2014",
month = "3",
day = "19",
doi = "10.1186/1471-2431-14-74",
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journal = "BMC Pediatrics",
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T1 - Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants

AU - Giannì, Maria L.

AU - Roggero, Paola

AU - Amato, Orsola

AU - Picciolini, Odoardo

AU - Piemontese, Pasqua

AU - Liotto, Nadia

AU - Taroni, Francesca

AU - Mosca, Fabio

PY - 2014/3/19

Y1 - 2014/3/19

N2 - 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.Trial registration: Current Controlled Trials (http://www.controlled-trials.com/ISRCTN30189842) London, UK.

AB - 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.Trial registration: Current Controlled Trials (http://www.controlled-trials.com/ISRCTN30189842) London, UK.

KW - Neurodevelopment

KW - Nutrient-enriched formula

KW - Post discharge nutrition

KW - Preterm infants

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