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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

Abstract

Background

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).

Objective

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.

Methods

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

Results

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.

Conclusions

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 ClinicalTrials.gov 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.

References

  1. Brion LP, Rosenfeld CR, Heyne R, Brown SL, Lair CS, Burchfield PJ, et al. Adjustable feedings plus accurate serial length measurements decrease discharge weight-length disproportion in very preterm infants: quality improvement project. J Perinatol. 2019;39:1131–9. Correction: J Perinatol. 2019 Dec;39(12):1694

    Article  Google Scholar 

  2. Brion LP, Rosenfeld CR, Heyne R, Brown LS, Lair CS, Petrosyan E, et al. Optimizing individual nutrition in preterm very low birth weight infants: double-blinded randomized controlled trial. J Perinatol. 2020;40:655–65.

    Article  Google Scholar 

  3. Brion LP, Rosenfeld CR, Heyne R, Brown LS, Lair CS, Heyne E, et al. Association of age of initiation and type and of complementary foods with body mass index and weight-length at twelve months of age in preterm infants. J Perinatol. 2020;40:1394–404. https://doi.org/10.1038/s41372-020-0637-x.

    Article  Google Scholar 

  4. Reis JD, Tolentino-Plata K, Heyne R, Brown LS, Rosenfeld CR, Caraig M, et al. Quality improvement project designed to reduce disproportionate growth in extremely low gestational age neonates: cognitive neurodevelopmental outcome at 18-41 months. J Perinatol. 2021;41:1050–8.

    Article  CAS  Google Scholar 

  5. Albers CA, Grieve AJ. Test Review: Bayley, N. Bayley Scales of Infant and Toddler Development– Third Edition. San Antonio, TX: Harcourt Assessment. J Psychoeducational Assess. 2007;25:180–90.

    Article  Google Scholar 

  6. Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978;92:529–34.

    Article  CAS  Google Scholar 

  7. Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001;163:1723–9. 433

    Article  CAS  Google Scholar 

  8. Olsen IE, Groveman SA, Lawson ML, Clark RH, Zemel BS. New intrauterine growth curves based on United States data. Pediatrics. 2010;125:e214–e224.

    Article  Google Scholar 

  9. Olsen IE, Lawson ML, Ferguson AN, Cantrell R, Grabich SC, Zemel BS, et al. BMI curves for preterm infants. Pediatrics. 2015;135:e572–e581.

    Article  Google Scholar 

  10. Duncan AF, Watterberg KL, Nolen TL, Vohr BR, Adams-Chapman I, Das A, et al. Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Effect of ethnicity and race on cognitive and language testing at age 18-22 months in extremely preterm infants. J Pediatr. 2012;160:966–71.e2.

    Article  Google Scholar 

  11. Lowe JR, Nolen TL, Vohr B, Adams-Chapman I, Duncan AF, Watterberg K. Effect of primary language on developmental testing in children born extremely preterm. Acta Paediatr. 2013;102:896–900.

    Article  Google Scholar 

  12. van Veen S, Remmers S, Aarnoudse-Moens CSH, Oosterlaan J, van Kaam AH, van Wassenaer-Leemhuis AG. Multilingualism was associated with lower cognitive outcomes in children who were born very and extremely preterm. Acta Paediatr. 2019;108:479–85.

    Article  Google Scholar 

  13. Rubio-Codina M, Grantham-McGregor S. Predictive validity in middle childhood of short tests of early childhood development used in large scale studies compared to the Bayley-III, the Family Care Indicators, height-for-age, and stunting: A longitudinal study in Bogota, Colombia. PLoS One. 2020;15:e0231317.

    Article  CAS  Google Scholar 

  14. Hoskens J, Klingels K, Smits-Engelsman B. Validity and cross-cultural differences of the Bayley Scales of Infant and Toddler Development, Third Edition in typically developing infants. Early Hum Dev. 2018;125:17–25.

    Article  Google Scholar 

  15. McHenry MS, Oyungu E, Yang Z, Hines AC, Ombitsa AR, Vreeman RC, et al. Cultural adaptation of the Bayley Scales of Infant and Toddler Development, 3rd Edition for use in Kenyan children aged 18-36 months: a psychometric study. Res Dev Disabil. 2021;110:103837.

    Article  Google Scholar 

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Funding

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

Authors

Contributions

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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Competing interests

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). https://doi.org/10.1038/s41372-022-01572-6

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