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Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial.
J Pediatr. 2018 11; 202:31-37.e2.JPed

Abstract

OBJECTIVE

To compare growth, feeding tolerance, and clinical and biochemical evaluations in human milk-fed preterm infants randomized to receive either an acidified or a nonacidified liquid human milk fortifier.

STUDY DESIGN

This prospective, controlled, parallel, multicenter growth and tolerance study included 164 preterm infants (≤32 weeks of gestation, birth weight 700-1500 g) who were randomized to acidified or nonacidified liquid human milk fortifier from study day 1, the first day of fortification, through study day 29 or until hospital discharge.

RESULTS

There was no difference in the primary outcome of weight gain from study days 1 to 29 (acidified liquid human milk fortifier, 16.4 ± 0.4 g/kg/day; nonacidified liquid human milk fortifier, 16.9 ± 0.4 g/kg/day). However, in both the intention-to-treat and the protocol evaluable analyses, infants fed nonacidified liquid human milk fortifier had significantly greater weight gain from study days 1 to 15 (17.9 g/kg/day vs 15.2 g/kg/day; P = .001). Infants fed with acidified liquid human milk fortifier received more protein (4.26 vs g/kg/day 4.11 g/kg/day, P = .0099) yet had lower blood urea nitrogen values (P = .010). The group fed acidified liquid human milk fortifier had more vomiting (10.3% vs 2.4%; P = .018), gastric residuals (12.8% vs 3.7%; P = .022), and metabolic acidosis (27% vs 5%; P < .001) in the intention-to-treat analysis and more abdominal distension (14.0% vs 1.7%; P = .015) in the protocol evaluable analysis.

CONCLUSIONS

Infants fed an acidified liquid human milk fortifier had higher rates of metabolic acidosis and poor feeding tolerance compared with infants fed a nonacidified liquid human milk fortifier. Initial weight gain was poorer with the acidified liquid human milk fortifier.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02307760.

Authors+Show Affiliations

Neonatal-Perinatal Medicine, Cohen Children's Medical Center, New Hyde Park, NY. Electronic address: schanler@northwell.edu.MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH.Abbott Nutrition, Columbus, OH.Pediatrix Medical Group, Memorial Hospital of South Bend, South Bend, IN.Baylor College of Medicine, Pediatrix Medical Group, North Central Baptist Hospital, San Antonio, TX.Abbott Nutrition, Columbus, OH.Abbott Nutrition, Columbus, OH.Abbott Nutrition, Columbus, OH.Department of Pediatrics, University of Louisville, Louisville, KY.

Pub Type(s)

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

Language

eng

PubMed ID

30195561

Citation

Schanler, Richard J., et al. "Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: a Prospective Randomized Clinical Trial." The Journal of Pediatrics, vol. 202, 2018, pp. 31-37.e2.
Schanler RJ, Groh-Wargo SL, Barrett-Reis B, et al. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. J Pediatr. 2018;202:31-37.e2.
Schanler, R. J., Groh-Wargo, S. L., Barrett-Reis, B., White, R. D., Ahmad, K. A., Oliver, J., Baggs, G., Williams, L., & Adamkin, D. (2018). Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. The Journal of Pediatrics, 202, 31-e2. https://doi.org/10.1016/j.jpeds.2018.07.005
Schanler RJ, et al. Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: a Prospective Randomized Clinical Trial. J Pediatr. 2018;202:31-37.e2. PubMed PMID: 30195561.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved Outcomes in Preterm Infants Fed a Nonacidified Liquid Human Milk Fortifier: A Prospective Randomized Clinical Trial. AU - Schanler,Richard J, AU - Groh-Wargo,Sharon L, AU - Barrett-Reis,Bridget, AU - White,Robert D, AU - Ahmad,Kaashif A, AU - Oliver,Jeffery, AU - Baggs,Geraldine, AU - Williams,Larry, AU - Adamkin,David, Y1 - 2018/09/05/ PY - 2018/02/13/received PY - 2018/06/26/revised PY - 2018/07/02/accepted PY - 2018/9/10/pubmed PY - 2019/3/1/medline PY - 2018/9/10/entrez KW - growth KW - human milk KW - metabolic acidosis KW - premature infant KW - randomized SP - 31 EP - 37.e2 JF - The Journal of pediatrics JO - J. Pediatr. VL - 202 N2 - OBJECTIVE: To compare growth, feeding tolerance, and clinical and biochemical evaluations in human milk-fed preterm infants randomized to receive either an acidified or a nonacidified liquid human milk fortifier. STUDY DESIGN: This prospective, controlled, parallel, multicenter growth and tolerance study included 164 preterm infants (≤32 weeks of gestation, birth weight 700-1500 g) who were randomized to acidified or nonacidified liquid human milk fortifier from study day 1, the first day of fortification, through study day 29 or until hospital discharge. RESULTS: There was no difference in the primary outcome of weight gain from study days 1 to 29 (acidified liquid human milk fortifier, 16.4 ± 0.4 g/kg/day; nonacidified liquid human milk fortifier, 16.9 ± 0.4 g/kg/day). However, in both the intention-to-treat and the protocol evaluable analyses, infants fed nonacidified liquid human milk fortifier had significantly greater weight gain from study days 1 to 15 (17.9 g/kg/day vs 15.2 g/kg/day; P = .001). Infants fed with acidified liquid human milk fortifier received more protein (4.26 vs g/kg/day 4.11 g/kg/day, P = .0099) yet had lower blood urea nitrogen values (P = .010). The group fed acidified liquid human milk fortifier had more vomiting (10.3% vs 2.4%; P = .018), gastric residuals (12.8% vs 3.7%; P = .022), and metabolic acidosis (27% vs 5%; P < .001) in the intention-to-treat analysis and more abdominal distension (14.0% vs 1.7%; P = .015) in the protocol evaluable analysis. CONCLUSIONS: Infants fed an acidified liquid human milk fortifier had higher rates of metabolic acidosis and poor feeding tolerance compared with infants fed a nonacidified liquid human milk fortifier. Initial weight gain was poorer with the acidified liquid human milk fortifier. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02307760. SN - 1097-6833 UR - https://www.unboundmedicine.com/medline/citation/30195561/Improved_Outcomes_in_Preterm_Infants_Fed_a_Nonacidified_Liquid_Human_Milk_Fortifier:_A_Prospective_Randomized_Clinical_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(18)30898-9 DB - PRIME DP - Unbound Medicine ER -