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Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial.
Curr Dev Nutr. 2019 Dec; 3(12):nzz129.CD

Abstract

Background

Bovine milk-based fortifiers (BMBF) have been standard of care for nutrient fortification of feeds for very low birth weight (VLBW) infants, however, there is increasing use of human milk-based fortifiers (HMBF) in neonatal care despite additional costs and limited supporting data. No randomized clinical trial has followed infants fed these fortifiers after initial hospitalization.

Objective

To compare neurodevelopment in infants born weighing <1250 g fed maternal milk with supplemental donor milk and either a HMBF or BMBF.

Methods

This is a follow-up of a completed pragmatic, triple-blind, parallel group randomized clinical trial conducted in Southern Ontario between August 2014 and March 2016 (NCT02137473) with feeding tolerance as the primary outcome. Infants weighing <1250 g at birth were block randomized by an online third-party service to receive either HMBF (n = 64) or BMBF (n = 63) added to maternal milk with supplemental donor milk during hospitalization. Neurodevelopment was assessed at 18-mo corrected age using the Bayley Scales of Infant and Toddler Development, Third Edition. Follow-up was completed in October 2017.

Results

Of the 127 infants randomized, 109 returned for neurodevelopmental assessment. No statistically significant differences between fortifiers were identified for cognitive composite scores [adjusted mean scores 94.7 in the HMBF group and 95.9 in the BMBF group; fully adjusted mean difference, -1.1 (95% CI: -6.5 to 4.4)], language composite scores [adjusted scores 92.4 in the HMBF group and 93.1 in the BMBF; fully adjusted mean difference, -1.2 (-7.5 to 5.1)], or motor composite scores [adjusted scores 95.6 in the HMBF group and 97.7 in the BMBF; fully adjusted mean difference, -1.1 (-6.3 to 4.2)]. There was no difference in the proportion of participants that died or had neurodevelopmental impairment or disability between groups.

Conclusions

Providing HMBF compared with BMBF does not improve neurodevelopmental scores at 18-mo corrected age in infants born <1250 g otherwise fed a human milk diet. This trial was registered at clinicaltrials.gov as NCT02137473.

Authors+Show Affiliations

Translational Medicine Program, The Hospital for Sick Children, Toronto, Canada.Translational Medicine Program, The Hospital for Sick Children, Toronto, Canada. Department of Nutritional Sciences, University of Toronto, Toronto, Canada.Translational Medicine Program, The Hospital for Sick Children, Toronto, Canada.Translational Medicine Program, The Hospital for Sick Children, Toronto, Canada.Translational Medicine Program, The Hospital for Sick Children, Toronto, Canada.Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Canada. Evaluative and Clinical Sciences, Sunnybrook Research Institute and the Institute of Health Policy, Toronto, Canada.Department of Paediatrics, Sinai Health System, Toronto, Canada.Division of Neonatology, The Hospital for Sick Children, Toronto, Canada.No affiliation info availableDepartment of Nutritional Sciences, University of Toronto, Toronto, Canada. Department of Paediatrics, Sinai Health System, Toronto, Canada. Division of Neonatology, The Hospital for Sick Children, Toronto, Canada. Department of Paediatrics, University of Toronto, Toronto, Canada.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32154499

Citation

Hopperton, Kathryn E., et al. "Nutrient Enrichment of Human Milk With Human and Bovine Milk-Based Fortifiers for Infants Born <1250 G: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial." Current Developments in Nutrition, vol. 3, no. 12, 2019, pp. nzz129.
Hopperton KE, O'Connor DL, Bando N, et al. Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. Curr Dev Nutr. 2019;3(12):nzz129.
Hopperton, K. E., O'Connor, D. L., Bando, N., Conway, A. M., Ng, D. V. Y., Kiss, A., Jackson, J., Ly, L., & Unger, S. L. (2019). Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. Current Developments in Nutrition, 3(12), nzz129. https://doi.org/10.1093/cdn/nzz129
Hopperton KE, et al. Nutrient Enrichment of Human Milk With Human and Bovine Milk-Based Fortifiers for Infants Born <1250 G: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. Curr Dev Nutr. 2019;3(12):nzz129. PubMed PMID: 32154499.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-Month Neurodevelopment Follow-Up of a Randomized Clinical Trial. AU - Hopperton,Kathryn E, AU - O'Connor,Deborah L, AU - Bando,Nicole, AU - Conway,Aisling M, AU - Ng,Dawn V Y, AU - Kiss,Alex, AU - Jackson,Jacqueline, AU - Ly,Linh, AU - ,, AU - Unger,Sharon L, Y1 - 2019/11/12/ PY - 2019/07/11/received PY - 2019/10/29/revised PY - 2019/11/05/accepted PY - 2020/3/11/entrez PY - 2020/3/11/pubmed PY - 2020/3/11/medline KW - bovine milk-based fortifier KW - donor milk KW - human milk KW - human milk-based fortifier KW - neurodevelopment KW - very low birth weight infants SP - nzz129 EP - nzz129 JF - Current developments in nutrition JO - Curr Dev Nutr VL - 3 IS - 12 N2 - Background: Bovine milk-based fortifiers (BMBF) have been standard of care for nutrient fortification of feeds for very low birth weight (VLBW) infants, however, there is increasing use of human milk-based fortifiers (HMBF) in neonatal care despite additional costs and limited supporting data. No randomized clinical trial has followed infants fed these fortifiers after initial hospitalization. Objective: To compare neurodevelopment in infants born weighing <1250 g fed maternal milk with supplemental donor milk and either a HMBF or BMBF. Methods: This is a follow-up of a completed pragmatic, triple-blind, parallel group randomized clinical trial conducted in Southern Ontario between August 2014 and March 2016 (NCT02137473) with feeding tolerance as the primary outcome. Infants weighing <1250 g at birth were block randomized by an online third-party service to receive either HMBF (n = 64) or BMBF (n = 63) added to maternal milk with supplemental donor milk during hospitalization. Neurodevelopment was assessed at 18-mo corrected age using the Bayley Scales of Infant and Toddler Development, Third Edition. Follow-up was completed in October 2017. Results: Of the 127 infants randomized, 109 returned for neurodevelopmental assessment. No statistically significant differences between fortifiers were identified for cognitive composite scores [adjusted mean scores 94.7 in the HMBF group and 95.9 in the BMBF group; fully adjusted mean difference, -1.1 (95% CI: -6.5 to 4.4)], language composite scores [adjusted scores 92.4 in the HMBF group and 93.1 in the BMBF; fully adjusted mean difference, -1.2 (-7.5 to 5.1)], or motor composite scores [adjusted scores 95.6 in the HMBF group and 97.7 in the BMBF; fully adjusted mean difference, -1.1 (-6.3 to 4.2)]. There was no difference in the proportion of participants that died or had neurodevelopmental impairment or disability between groups. Conclusions: Providing HMBF compared with BMBF does not improve neurodevelopmental scores at 18-mo corrected age in infants born <1250 g otherwise fed a human milk diet. This trial was registered at clinicaltrials.gov as NCT02137473. SN - 2475-2991 UR - https://www.unboundmedicine.com/medline/citation/32154499/Nutrient_Enrichment_of_Human_Milk_with_Human_and_Bovine_Milk-Based_Fortifiers_for_Infants_Born_<1250_g:_18-Month_Neurodevelopment_Follow-Up_of_a_Randomized_Clinical_Trial L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/32154499/ DB - PRIME DP - Unbound Medicine ER -
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