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Open AccessArticle

Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial

Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari “Aldo Moro”, Policlinico, Piazza G. Cesare 11, 70124 Bari, Italy
Medical Statistics, Department of Interdisciplinary Medicine, University of Bari “Aldo Moro”, 70124 Bari, Italy
Mead Johnson Nutrition, Department of Medical Affairs, Evansville, IN 47721, USA
Author to whom correspondence should be addressed.
Int. J. Environ. Res. Public Health 2019, 16(16), 2911;
Received: 4 July 2019 / Revised: 5 August 2019 / Accepted: 10 August 2019 / Published: 14 August 2019
(This article belongs to the Special Issue Preterm Birth: Research, Intervention and Developmental Outcomes)
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Background: This study was carried out to evaluate enteral feeding advancement and tolerance in preterm infants receiving one of two marketed formulas: intact protein preterm formula (IPF) or extensively hydrolyzed formula (EHF) for the first 14 feeding days. Methods: Primary outcome was days to full enteral feeding (≥140 mL/kg/day). Per protocol analyses included the following: all participants who met study entrance criteria and completed study feeding (primary) and those who received ≥75% enteral intake from study formula (subset). Mothers were encouraged to provide their breast milk. Results: Of the 65 enrolled (IPF: n = 32; EHF: n = 33), 60 completed study feeding per protocol (IPF: n = 30; EHF: n = 30), 37 (62%) received predominantly breast milk, and 23 (38%) received ≥75% study formula intake (IPF: n = 11; EHF: n = 12). No group differences were detected in tolerance measures. No necrotizing enterocolitis (NEC) was reported. Median time to achievement of full enteral feeding was significantly shorter for the IPF vs. EHF group (day 10 vs. 14, p < 0.05) (subset analysis). Mean enteral intake significantly increased by day 14 for the IPF group (p < 0.05), reflecting group divergence as achieved feeding volumes increased. Conclusions: Results suggest shorter time to full enteral feeding and higher feeding volume achieved by study end in preterm infants receiving intact protein preterm formula versus extensively hydrolyzed formula. View Full-Text
Keywords: infant; premature; infant formula; enteral nutrition infant; premature; infant formula; enteral nutrition

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Baldassarre, M.E.; Di Mauro, A.; Fanelli, M.; Capozza, M.; Wampler, J.L.; Cooper, T.; Laforgia, N. Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial. Int. J. Environ. Res. Public Health 2019, 16, 2911.

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