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Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial.
Am J Clin Nutr. 2018 07 01; 108(1):108-116.AJ

Abstract

Background

Human milk-based fortifiers (HMBFs) are being adopted in neonatal care to enrich the nutrients in human milk for very low birth weight (VLBW) infants despite being costly and there being limited efficacy data. No randomized clinical trial has evaluated the use of HMBF compared with bovine milk-based fortifiers (BMBFs) in the absence of formula feeding.

Objective

To determine if HMBF compared with BMBF for routine nutrient enrichment of human milk improves feeding tolerance, reduces morbidity, reduces fecal calprotectin (a measure of gut inflammation), and supports the growth of infants <1250 g.

Design

In this blinded randomized clinical trial, infants born weighing <1250 g were recruited from neonatal units in Ontario, Canada between August 2014 and November 2015. The infants were fed mother's milk and donor milk as required. Fortification commenced at 100 mL/kg per day of HMBF (0.81 kcal/mL) or BMBF (0.72 kcal/mL) and advanced at 140 mL/kg per day to 0.88 and 0.78 kcal/mL, respectively. The primary outcome was percentage of infants with a feeding interruption for ≥12 h or a >50% reduction in feeding volume. Secondary outcomes included a dichotomous mortality and morbidity index (i.e., affirmative for any one of death, late-onset sepsis, necrotizing enterocolitis, chronic lung disease, or severe retinopathy of prematurity), fecal calprotectin, and growth.

Results

Of 232 eligible infants, 127 (54.7%) were randomized (n = 64 HMBF, n = 63 BMBF). Mean ± SD birth weight and gestational age of infants were 888 ± 201 g and 27.7 ± 2.5 wk, respectively. No statistically significant differences were identified in feeding interruptions [17/64 HMBF, 20/61 BMBF; unadjusted risk difference: -6.2% (95% CI: -22.2%, 9.8%)]. There was no statistically significant difference in the mortality and morbidity index (48.4% HMBF, 49.2% BMBF, adjusted P = 0.76), changes in fecal calprotectin, or growth z scores.

Conclusions

Among infants born weighing <1250 g and exclusively fed human milk, the use of HMBF did not improve feeding tolerance or reduce mortality and morbidity compared with BMBF. This trial was registered at clinicaltrials.gov as NCT02137473.

Authors+Show Affiliations

Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada. Departments of Nutritional Sciences, Pediatrics, and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada. Department of Pediatrics, Sinai Health System, Toronto, Canada.Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada. Evaluative and Clinical Sciences, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada. Translational Medicine Program and Divisions of Neonatology, The Hospital for Sick Children, Toronto, Canada. Departments of Nutritional Sciences, Pediatrics, and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada. Departments of Pediatrics and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.Trillium Health Partners, Mississauga, Canada.Translational Medicine Program and Divisions of Neonatology, The Hospital for Sick Children, Toronto, Canada. Departments of Pediatrics and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada. St. Michael's Hospital and Li Ka Shing Knowledge Institute, Toronto, Canada.Translational Medicine Program and Divisions of Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada. Departments of Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada. Departments of Nutritional Sciences, Pediatrics, and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada.Department of Pediatrics, Sinai Health System, Toronto, Canada.Departments of Pediatrics and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada. Department of Pediatrics, Sinai Health System, Toronto, Canada.Department of Pediatrics, William Osler Health System, Brampton, Canada.Translational Medicine Program and Divisions of Neonatology and Diagnostic Imaging, The Hospital for Sick Children, Toronto, Canada.Translational Medicine Program and Divisions of Neonatology, The Hospital for Sick Children, Toronto, Canada. Departments of Pediatrics and Medical Imaging, Sunnybrook Research Institute, University of Toronto, Toronto, Canada. Department of Pediatrics, Sinai Health System, Toronto, Canada.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29878061

Citation

O'Connor, Deborah L., et al. "Nutrient Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Infants Born Weighing <1250 G: a Randomized Clinical Trial." The American Journal of Clinical Nutrition, vol. 108, no. 1, 2018, pp. 108-116.
O'Connor DL, Kiss A, Tomlinson C, et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial. Am J Clin Nutr. 2018;108(1):108-116.
O'Connor, D. L., Kiss, A., Tomlinson, C., Bando, N., Bayliss, A., Campbell, D. M., Daneman, A., Francis, J., Kotsopoulos, K., Shah, P. S., Vaz, S., Williams, B., & Unger, S. (2018). Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial. The American Journal of Clinical Nutrition, 108(1), 108-116. https://doi.org/10.1093/ajcn/nqy067
O'Connor DL, et al. Nutrient Enrichment of Human Milk With Human and Bovine Milk-based Fortifiers for Infants Born Weighing <1250 G: a Randomized Clinical Trial. Am J Clin Nutr. 2018 07 1;108(1):108-116. PubMed PMID: 29878061.
* 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 weighing <1250 g: a randomized clinical trial. AU - O'Connor,Deborah L, AU - Kiss,Alex, AU - Tomlinson,Christopher, AU - Bando,Nicole, AU - Bayliss,Ann, AU - Campbell,Douglas M, AU - Daneman,Alan, AU - Francis,Jane, AU - Kotsopoulos,Kirsten, AU - Shah,Prakesh S, AU - Vaz,Simone, AU - Williams,Brock, AU - Unger,Sharon, AU - ,, PY - 2018/01/09/received PY - 2018/03/14/accepted PY - 2018/6/8/pubmed PY - 2019/8/3/medline PY - 2018/6/8/entrez SP - 108 EP - 116 JF - The American journal of clinical nutrition JO - Am. J. Clin. Nutr. VL - 108 IS - 1 N2 - Background: Human milk-based fortifiers (HMBFs) are being adopted in neonatal care to enrich the nutrients in human milk for very low birth weight (VLBW) infants despite being costly and there being limited efficacy data. No randomized clinical trial has evaluated the use of HMBF compared with bovine milk-based fortifiers (BMBFs) in the absence of formula feeding. Objective: To determine if HMBF compared with BMBF for routine nutrient enrichment of human milk improves feeding tolerance, reduces morbidity, reduces fecal calprotectin (a measure of gut inflammation), and supports the growth of infants <1250 g. Design: In this blinded randomized clinical trial, infants born weighing <1250 g were recruited from neonatal units in Ontario, Canada between August 2014 and November 2015. The infants were fed mother's milk and donor milk as required. Fortification commenced at 100 mL/kg per day of HMBF (0.81 kcal/mL) or BMBF (0.72 kcal/mL) and advanced at 140 mL/kg per day to 0.88 and 0.78 kcal/mL, respectively. The primary outcome was percentage of infants with a feeding interruption for ≥12 h or a >50% reduction in feeding volume. Secondary outcomes included a dichotomous mortality and morbidity index (i.e., affirmative for any one of death, late-onset sepsis, necrotizing enterocolitis, chronic lung disease, or severe retinopathy of prematurity), fecal calprotectin, and growth. Results: Of 232 eligible infants, 127 (54.7%) were randomized (n = 64 HMBF, n = 63 BMBF). Mean ± SD birth weight and gestational age of infants were 888 ± 201 g and 27.7 ± 2.5 wk, respectively. No statistically significant differences were identified in feeding interruptions [17/64 HMBF, 20/61 BMBF; unadjusted risk difference: -6.2% (95% CI: -22.2%, 9.8%)]. There was no statistically significant difference in the mortality and morbidity index (48.4% HMBF, 49.2% BMBF, adjusted P = 0.76), changes in fecal calprotectin, or growth z scores. Conclusions: Among infants born weighing <1250 g and exclusively fed human milk, the use of HMBF did not improve feeding tolerance or reduce mortality and morbidity compared with BMBF. This trial was registered at clinicaltrials.gov as NCT02137473. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/29878061/Nutrient_enrichment_of_human_milk_with_human_and_bovine_milk_based_fortifiers_for_infants_born_weighing_<1250_g:_a_randomized_clinical_trial_ L2 - https://academic.oup.com/ajcn/article-lookup/doi/10.1093/ajcn/nqy067 DB - PRIME DP - Unbound Medicine ER -