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Double-blinded randomized controlled trial of optimizing nutrition in preterm very low birth weight infants: Bayley scores at 18–38 months of age



Human milk supplementation for preterm infants in the neonatal intensive care unit (NICU) can be based on optimized nutrition (feeding adjustments based on growth and measurements of serum nutrients) or individualized nutrition (measurements of macronutrients in mother’s own milk).


To compare Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) at 18–38mo adjusted age in infants who had been randomly allocated to individualized+optimized nutrition (experimental group) vs optimized nutrition alone (control) in the NICU.


Double-blinded randomized controlled trial in neonates <29wks gestational age (GA) and those <34wks GA and small for GA.


Bayley scores were assessed in 91/114 (80%) infants. The two study groups had similar frequencies of low cognitive, motor and language Bayley scores and similar age-adjusted Bayley scores in bivariate and multivariate analyses.


The type of human milk supplementation provided had no significant effect on Bayley scores assessed at 18–38mo.

Trial registration

This randomized controlled trial was registered at NCT02372136.

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Fig. 1: CONSORT diagram.

Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. Preliminary data were presented as follows: JDR, KT-P, MC, RH, CRR, LSB, LPB. Double-Blinded Randomized Controlled Trial (RCT) of Optimizing Nutrition in Preterm (PT) Very Low Birth Weight Infants: Bayley Scores at >18 Months of Age. Oral poster symposium, PAS, Denver, CO, 4/24/2022.


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The RCT was supported by a National Grant from the Gerber Foundation (LPB), George L. MacGregor Professorship (CRR) and Children’s Medical Center Clinical Advisory Committee (CCRAC)—Senior Investigator Research Award—New Direction (LPB). The follow-up was supported by the latter two sources. The study sponsors had no role in design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review and approval of the manuscript, and decision to submit the manuscript for publication.

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Authors and Affiliations



JDR, RH, CRR and LPB conceptualized and designed the study. KT-P, MS conducted the Bayley score assessments. MC, RN was the research coordinator for the QI project. SB, MS conducted statistical analyses. All authors participated in the interpretation of the data, critically reviewed the revisions, and approved the final manuscript as submitted.

Corresponding author

Correspondence to Luc P. Brion.

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The authors declare no competing interests.

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Reis, J.D., Tolentino-Plata, K., Caraig, M. et al. Double-blinded randomized controlled trial of optimizing nutrition in preterm very low birth weight infants: Bayley scores at 18–38 months of age. J Perinatol 43, 81–85 (2023).

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