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Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial.
JAMA Pediatr. 2017 01 01; 171(1):16-22.JP

Abstract

Importance

Protein, supplied in currently available commercial fortifiers, may be inadequate to meet the requirements of very preterm infants; in addition, intraindividual and interindividual variability of human milk protein and energy content potentially contribute to unsatisfactory early postnatal growth.

Objective

To determine effects on growth of different levels of enteral protein supplementation in predominantly human milk-fed preterm infants.

Design, Setting, and Participants

This randomized clinical and partially blinded single-center trial was conducted in a neonatal tertiary referral center in Germany. Sixty preterm infants (gestation <32 weeks and weight <1500 g at birth) were recruited from October 2012 to October 2014 and included 35% of 173 eligible infants. Median (interquartile range [IQR]) gestational age at birth was 29.9 (28.7-31.2) weeks. All analyses were conducted in an intention-to-treat population.

Interventions

Infants were randomly assigned to either a lower-protein (adding 1 g of bovine protein/100 mL of breast milk through a commercial human milk fortifier; n = 30) or a higher-protein group at a median (IQR) postnatal age of 7 (6-8) days. The higher-protein group (n = 30) received either standardized higher-protein supplementation (study fortifier adding 1.8 g of bovine protein/100 mL of breast milk [n = 15]) or individualized high-protein supplementation based on protein and fat content of administered breast milk (n = 15). Study interventions were continued for a median (IQR) of 41 (30-57) days and until definite discharge planning.

Main Outcomes and Measures

Primary outcome was weight gain (g/kg/d) from birth to the end of intervention.

Results

Sixty preterm infants (gestation <32 weeks and weight <1500 g at birth), 33 girls, were recruited from October 2012 to October 2014 and included 35% of 173 eligible infants. Median (IQR) gestational age at birth was 29.9 (28.7-31.2) weeks. Demographic characteristics and hospital courses were similar in both groups, and birth weights ranged from 580 to 1495 g in the lower-protein group and 490 to 1470 g in the higher-protein group. Weight gain was similar in the lower- and higher-protein groups: mean (95% CI), 16.3 g/kg/d (15.4-17.1 g/kg/d) in the lower-protein group vs 16.0 g/kg/d (15.1-16.9 g/kg/d) in the higher-protein group) (P = .70), despite an increase in actual protein intake by 0.6 g/kg/d (0.4-0.7 g/kg/d) (P < .001). Head circumference and lower leg longitudinal growth were also similar, as was the proportion of cumulative total enteral feeding volume provided as breast milk: median (IQR) proportion of breast milk, 92% (79%-98%) in the lower-protein group vs 94% (62%-99%) in the higher-protein group (P = .89).

Conclusions and Relevance

An increase in protein intake by 0.6 g/kg/d to a mean intake of 4.3 g/kg/d did not further enhance growth of very preterm infants with a median birth weight of 1200 g, who achieved near-fetal growth rates. This might point to a ceiling effect for enteral protein intake with respect to its influence on growth.

Trial Registration

clinicaltrials.gov Identifier: NCT01773902.

Authors+Show Affiliations

Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Division of Endocrinology, Diabetology, Vascular Medicine, Nephrology and Clinical Chemistry, and Pathobiochemistry, Department of Internal Medicine IV, University of Tuebingen, Tuebingen, Germany3Institute of Diabetes Research and Metabolic Diseases (IDM) of the Helmholtz Center Munich, University of Tuebingen, Tuebingen, Germany4German Center for Diabetes Research (DZD), Muenchen-Neuherberg, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.Department of Neonatology, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany5Center for Pediatric Clinical Studies, University Children's Hospital, Eberhard-Karls University, Tuebingen, Germany.

Pub Type(s)

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

Language

eng

PubMed ID

27893064

Citation

Maas, Christoph, et al. "Effect of Increased Enteral Protein Intake On Growth in Human Milk-Fed Preterm Infants: a Randomized Clinical Trial." JAMA Pediatrics, vol. 171, no. 1, 2017, pp. 16-22.
Maas C, Mathes M, Bleeker C, et al. Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017;171(1):16-22.
Maas, C., Mathes, M., Bleeker, C., Vek, J., Bernhard, W., Wiechers, C., Peter, A., Poets, C. F., & Franz, A. R. (2017). Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. JAMA Pediatrics, 171(1), 16-22. https://doi.org/10.1001/jamapediatrics.2016.2681
Maas C, et al. Effect of Increased Enteral Protein Intake On Growth in Human Milk-Fed Preterm Infants: a Randomized Clinical Trial. JAMA Pediatr. 2017 01 1;171(1):16-22. PubMed PMID: 27893064.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Increased Enteral Protein Intake on Growth in Human Milk-Fed Preterm Infants: A Randomized Clinical Trial. AU - Maas,Christoph, AU - Mathes,Michaela, AU - Bleeker,Christine, AU - Vek,Julia, AU - Bernhard,Wolfgang, AU - Wiechers,Cornelia, AU - Peter,Andreas, AU - Poets,Christian F, AU - Franz,Axel R, PY - 2016/11/29/pubmed PY - 2017/6/27/medline PY - 2016/11/29/entrez SP - 16 EP - 22 JF - JAMA pediatrics JO - JAMA Pediatr VL - 171 IS - 1 N2 - Importance: Protein, supplied in currently available commercial fortifiers, may be inadequate to meet the requirements of very preterm infants; in addition, intraindividual and interindividual variability of human milk protein and energy content potentially contribute to unsatisfactory early postnatal growth. Objective: To determine effects on growth of different levels of enteral protein supplementation in predominantly human milk-fed preterm infants. Design, Setting, and Participants: This randomized clinical and partially blinded single-center trial was conducted in a neonatal tertiary referral center in Germany. Sixty preterm infants (gestation <32 weeks and weight <1500 g at birth) were recruited from October 2012 to October 2014 and included 35% of 173 eligible infants. Median (interquartile range [IQR]) gestational age at birth was 29.9 (28.7-31.2) weeks. All analyses were conducted in an intention-to-treat population. Interventions: Infants were randomly assigned to either a lower-protein (adding 1 g of bovine protein/100 mL of breast milk through a commercial human milk fortifier; n = 30) or a higher-protein group at a median (IQR) postnatal age of 7 (6-8) days. The higher-protein group (n = 30) received either standardized higher-protein supplementation (study fortifier adding 1.8 g of bovine protein/100 mL of breast milk [n = 15]) or individualized high-protein supplementation based on protein and fat content of administered breast milk (n = 15). Study interventions were continued for a median (IQR) of 41 (30-57) days and until definite discharge planning. Main Outcomes and Measures: Primary outcome was weight gain (g/kg/d) from birth to the end of intervention. Results: Sixty preterm infants (gestation <32 weeks and weight <1500 g at birth), 33 girls, were recruited from October 2012 to October 2014 and included 35% of 173 eligible infants. Median (IQR) gestational age at birth was 29.9 (28.7-31.2) weeks. Demographic characteristics and hospital courses were similar in both groups, and birth weights ranged from 580 to 1495 g in the lower-protein group and 490 to 1470 g in the higher-protein group. Weight gain was similar in the lower- and higher-protein groups: mean (95% CI), 16.3 g/kg/d (15.4-17.1 g/kg/d) in the lower-protein group vs 16.0 g/kg/d (15.1-16.9 g/kg/d) in the higher-protein group) (P = .70), despite an increase in actual protein intake by 0.6 g/kg/d (0.4-0.7 g/kg/d) (P < .001). Head circumference and lower leg longitudinal growth were also similar, as was the proportion of cumulative total enteral feeding volume provided as breast milk: median (IQR) proportion of breast milk, 92% (79%-98%) in the lower-protein group vs 94% (62%-99%) in the higher-protein group (P = .89). Conclusions and Relevance: An increase in protein intake by 0.6 g/kg/d to a mean intake of 4.3 g/kg/d did not further enhance growth of very preterm infants with a median birth weight of 1200 g, who achieved near-fetal growth rates. This might point to a ceiling effect for enteral protein intake with respect to its influence on growth. Trial Registration: clinicaltrials.gov Identifier: NCT01773902. SN - 2168-6211 UR - https://www.unboundmedicine.com/medline/citation/27893064/Effect_of_Increased_Enteral_Protein_Intake_on_Growth_in_Human_Milk_Fed_Preterm_Infants:_A_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jamapediatrics/fullarticle/10.1001/jamapediatrics.2016.2681 DB - PRIME DP - Unbound Medicine ER -