Top

Published in:

Open Access 01-12-2014 | Research article

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

Authors: Maria Lorella Giannì, Paola Roggero, Orsola Amato, Odoardo Picciolini, Pasqua Piemontese, Nadia Liotto, Francesca Taroni, Fabio Mosca

Published in: BMC Pediatrics | Issue 1/2014

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.

Available only for authorised users

Serenius F, Källén K, Blennow M, Ewald U, Fellman V, Holmström G, Lindberg E, Lundqvist P, Maršál K, Norman M, Olhager E, Stigson L, Stjernqvist K, Vollmer B, Strömberg B, EXPRESS Group: Neurodevelopmental outcome in extremely preterm infants at 2.5 years after active perinatal care in Sweden. JAMA. 2013, 309: 1810-1820. 10.1001/jama.2013.3786.CrossRefPubMed

Franz AR, Pohlandt F, Bode H, Mihatsch WA, Sander S, Kron M, Steinmacher J: Intrauterine, early neonatal and post discharge growth and neurodevelopmental outcome at 5.4 years in extremely preterm infants after intensive nutritional support. Pediatrics. 2009, 123: e101-e109. 10.1542/peds.2008-1352.CrossRefPubMed

Georgieff MK: Nutrition and the developing brain: nutrient priorities and measurement. Am J Clin Nutr. 2007, 85 (Suppl 2): 614-620.

Tan M, Abernethy L, Cooke R: Improving head growth in preterm infants–a randomised controlled trial II: MRI and developmental outcomes in the first year. Arch Dis Child Fetal Neonatal Ed. 2008, 93: F342-F346. 10.1136/adc.2007.124255.CrossRefPubMed

Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR: First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009, 123: 1337-1343. 10.1542/peds.2008-0211.CrossRefPubMed

Agosti M, Vegni C, Calciolari G, Marini A, GAMMA Study Group: Post-discharge nutrition of the very low-birthweight infant: interim results of the multicentric GAMMA study. Acta Paediatr Suppl. 2003, 91: 39-43.PubMed

Roggero P, Giannì ML, Amato O, Liotto N, Morlacchi L, Orsi A, Piemontese P, Taroni F, Morniroli D, Bracco B, Mosca F: Growth and fat-free mass gain in preterm infants after discharge: a randomized controlled trial. Pediatrics. 2012, 130: e1215-e1221. 10.1542/peds.2012-1193.CrossRefPubMed

Agostoni C, Decsi T, Fewtrell M, Goulet O, Kolacek S, Koletzko B, Michaelsen KF, Moreno L, Puntis J, Rigo J, Shamir R, Szajewska H, Turck D, van Goudoever J, ESPGHAN Committee on Nutrition: Complementary feeding: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2008, 46: 99-110. 10.1097/01.mpg.0000304464.60788.bd.CrossRefPubMed

Fenton TR: A new growth chart for preterm babies: Babson and Benda's chart updated with recent data and a new format. BMC Pediatr. 2003, 3: 13-10.1186/1471-2431-3-13.CrossRefPubMedPubMedCentral

10.

Rademaker KJ, Uiterwaal CS, Beek FJ, van Haastert IC, Lieftink AF, Groenendaal F, Grobbee DE, de Vries LS: Neonatal cranial ultrasound versus MRI and neurodevelopmental outcome at school age in children born preterm. Arch Dis Child Fetal Neonatal Ed. 2005, 90: F489-F493. 10.1136/adc.2005.073908.CrossRefPubMedPubMedCentral

11.

Agostoni C, Grandi F, Giannì ML, Silano M, Torcoletti M, Giovannini M, Riva E: Growth patterns of breast fed and formula fed infants in the first 12 months of life: an Italian study. Arch Dis Child. 1999, 81: 395-399. 10.1136/adc.81.5.395.CrossRefPubMedPubMedCentral

12.

Griffiths R: The abilities of young children: a comprehensive system of mental measurement for the first 8 years of life edited by child development research centre London. 1970, Young and Son: London, England

13.

Marini A, Vegni C, Gangi S, Benedetti V, Agosti M: Influence of different types of post-discharge feeding on somatic growth, cognitive development and their correlation in very low birthweight preterm infants. Acta Paediatr Suppl. 2003, 91: 18-33.PubMed

14.

Lafeber HN, van de Lagemaat M, Rotteveel J, van Weissenbruch M: Timing of nutritional interventions in very-low-birth-weight infants: optimal neurodevelopment compared with the onset of the metabolic syndrome. Am J Clin Nutr. 2013, 98 (Suppl): 556-560.CrossRef

15.

Stephens BE, Vohr BR: Neurodevelopmental outcome of the premature infant. Pediatr Clin North Am. 2009, 56: 631-646. 10.1016/j.pcl.2009.03.005.CrossRefPubMed

16.

Young L, Morgan J, McCormick FM, McGuire W: Nutrient-enriched formula versus standard term formula for preterm infants following hospital discharge. Cochrane Database Syst Rev. 2012, 3: CD004696-PubMed

17.

Cooke RJ, Embleton ND, Griffin IJ, Wells JC, McCormick KP: Feeding preterm infants after hospital discharge: growth and development at 18 months of age. Pediatr Res. 2001, 49: 719-722. 10.1203/00006450-200105000-00018.CrossRefPubMed

18.

Lucas A, Fewtrell MS, Morley R, Singhal A, Abbott RA, Isaacs E, Stephenson T, MacFadyen UM, Clements H: Randomized trial of nutrient-enriched formula versus standard formula for postdischarge preterm infants. Pediatrics. 2001, 108: 703-711. 10.1542/peds.108.3.703.CrossRefPubMed

19.

Jeon GW, Jung YJ, Koh SY, Lee YK, Kim KA, Shin SM, Kim SS, Shim JW, Chang YS, Park WS: Preterm infants fed nutrient-enriched formula until 6 months show improved growth and development. Pediatr Int. 2011, 53: 683-688. 10.1111/j.1442-200X.2011.03332.x.CrossRefPubMed

20.

Aimone A, Rovet J, Ward W, Jefferies A, Campbell DM, Asztalos E, Feldman M, Vaughan J, Westall C, Whyte H, O'Connor DL, Post-Discharge Feeding Study Group: Growth and body composition of human milk-fed premature infants provided with extra energy and nutrients early after hospital discharge: 1-year follow-up. J Pediatr Gastroenterol Nutr. 2009, 49: 456-466. 10.1097/MPG.0b013e31819bc94b.CrossRefPubMed

21.

Lucas A, Morley R, Cole TJ, Gore SM, Lucas PJ, Crowle P, Pearse R, Boon AJ, Powell R: Early diet in preterm babies and developmental status at 18 months. Lancet. 1990, 335: 1477-1481. 10.1016/0140-6736(90)93026-L.CrossRefPubMed

22.

Lucas A, Morley R, Cole TJ: Randomised trial of early diet in preterm babies and later intelligence quotient. BMJ. 1998, 317: 1481-1487. 10.1136/bmj.317.7171.1481.CrossRefPubMedPubMedCentral

23.

Isaacs EB, Morley R, Lucas A: Early diet and general cognitive outcome at adolescence in children born at or below 30 weeks gestation. J Pediatr. 2009, 155: 229-234. 10.1016/j.jpeds.2009.02.030.CrossRefPubMed

24.

Bhatia J, Rassin DK, Cerreto MC, Bee DE: Effect of protein/energy ratio on growth and behavior of premature infants: preliminary findings. J Pediatr. 1991, 119: 103-110. 10.1016/S0022-3476(05)81048-0.CrossRefPubMed

The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2431/14/74/prepub

Title: Randomized outcome trial of nutrient-enriched formula and neurodevelopment outcome in preterm infants
Authors: Maria Lorella Giannì
Paola Roggero
Orsola Amato
Odoardo Picciolini
Pasqua Piemontese
Nadia Liotto
Francesca Taroni
Fabio Mosca
Publication date: 01-12-2014
Publisher: BioMed Central
Published in: BMC Pediatrics / Issue 1/2014
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/1471-2431-14-74

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2014

Is parenting style a predictor of suicide attempts in a representative sample of adolescents?

Hypotonic male infant and MCT8 deficiency - a diagnosis to think about

Secondhand smoke exposure assessment and counseling in the Chinese pediatric setting: a qualitative study

Study protocol: effects of the THAO-child health intervention program on the prevention of childhood obesity - The POIBC study

Birth after preeclamptic pregnancies: association with allergic sensitization and allergic rhinoconjunctivitis in late childhood; a historically matched cohort study

Late-onset volvulus without malrotation in extremely preterm infants - a case-control-study