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Updated: May 2, 2026
Assessment and Evaluation of the High Risk Neonate: The NICU Network Neurobehavioral Scale
Published on: August 25, 2014
Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants
Maria Lorella Giannì1, Paola Roggero, Orsola Amato
1NICU, 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.
Insights
Nutrient-enriched formula did not improve neurodevelopment in preterm infants. This study found no significant difference in neurodevelopmental outcomes at 24 months corrected age for infants fed enriched formula versus standard formula.
Area of Science:
- Neonatal nutrition
- Pediatric neurodevelopment
- Growth and development
Background:
- Preterm infants face risks for adverse neurodevelopment.
- Early nutrition is crucial for supporting neurodevelopmental trajectories.
- Post-discharge nutrition strategies require further investigation.
Purpose of the Study:
- To evaluate the impact of a nutrient-enriched formula on neurodevelopment in preterm infants after hospital discharge.
- To assess neurodevelopmental outcomes at 24 months corrected age.
- To compare outcomes between infants receiving enriched formula and standard formula.
Main Methods:
- Observer-blinded, single-center randomized controlled trial.
- Inclusion of preterm infants (gestational age < 32 weeks or birth weight < 1500 g) with limited human milk intake.
- Neurodevelopmental assessment at 24 months corrected age using the Griffiths Mental Development Scale.
Main Results:
- No significant difference in the general quotient at 24 months corrected age between enriched formula and standard formula groups.
- Similar scores across subscales (locomotor, personal-social, hearing/speech, hand/eye coordination, performance) in both groups.
- Study included 181 infants who completed the trial.
Conclusions:
- Post-discharge feeding with nutrient-enriched formula does not enhance neurodevelopment in preterm infants at 24 months corrected age.
- No significant benefits observed in either appropriate for gestational age (AGA) or small for gestational age (SGA) infants.
- Findings suggest current nutritional interventions may not alter long-term neurodevelopmental outcomes in healthy preterm infants.
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.
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