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

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 ful...

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Main Authors: Maria Elisabetta Baldassarre, Antonio Di Mauro, Margherita Fanelli, Manuela Capozza, Jennifer L. Wampler, Timothy Cooper, Nicola Laforgia
Format: Article
Language:English
Published: MDPI AG 2019-08-01
Series:International Journal of Environmental Research and Public Health
Subjects:
Online Access:https://www.mdpi.com/1660-4601/16/16/2911
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spelling doaj-3058aa8ba33342ca993cd20b2e3ea4862020-11-25T01:18:49ZengMDPI AGInternational Journal of Environmental Research and Public Health1660-46012019-08-011616291110.3390/ijerph16162911ijerph16162911Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled TrialMaria Elisabetta Baldassarre0Antonio Di Mauro1Margherita Fanelli2Manuela Capozza3Jennifer L. Wampler4Timothy Cooper5Nicola Laforgia6Neonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari “Aldo Moro”, Policlinico, Piazza G. Cesare 11, 70124 Bari, ItalyNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari “Aldo Moro”, Policlinico, Piazza G. Cesare 11, 70124 Bari, ItalyMedical Statistics, Department of Interdisciplinary Medicine, University of Bari “Aldo Moro”, 70124 Bari, ItalyNeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari “Aldo Moro”, Policlinico, Piazza G. Cesare 11, 70124 Bari, ItalyMead Johnson Nutrition, Department of Medical Affairs, Evansville, IN 47721, USAMead Johnson Nutrition, Department of Medical Affairs, Evansville, IN 47721, USANeonatology and Neonatal Intensive Care Unit, Department of Biomedical Science and Human Oncology, University of Bari “Aldo Moro”, Policlinico, Piazza G. Cesare 11, 70124 Bari, ItalyBackground: 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 (&#8805;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 &#8805;75% enteral intake from study formula (subset). Mothers were encouraged to provide their breast milk. Results: Of the 65 enrolled (IPF: <i>n</i> = 32; EHF: <i>n</i> = 33), 60 completed study feeding per protocol (IPF: <i>n</i> = 30; EHF: <i>n</i> = 30), 37 (62%) received predominantly breast milk, and 23 (38%) received &#8805;75% study formula intake (IPF: <i>n</i> = 11; EHF: <i>n</i> = 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, <i>p</i> &lt; 0.05) (subset analysis). Mean enteral intake significantly increased by day 14 for the IPF group (<i>p</i> &lt; 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.https://www.mdpi.com/1660-4601/16/16/2911infantprematureinfant formulaenteral nutrition
collection DOAJ
language English
format Article
sources DOAJ
author Maria Elisabetta Baldassarre
Antonio Di Mauro
Margherita Fanelli
Manuela Capozza
Jennifer L. Wampler
Timothy Cooper
Nicola Laforgia
spellingShingle Maria Elisabetta Baldassarre
Antonio Di Mauro
Margherita Fanelli
Manuela Capozza
Jennifer L. Wampler
Timothy Cooper
Nicola Laforgia
Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
International Journal of Environmental Research and Public Health
infant
premature
infant formula
enteral nutrition
author_facet Maria Elisabetta Baldassarre
Antonio Di Mauro
Margherita Fanelli
Manuela Capozza
Jennifer L. Wampler
Timothy Cooper
Nicola Laforgia
author_sort Maria Elisabetta Baldassarre
title Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
title_short Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
title_full Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
title_fullStr Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
title_full_unstemmed Shorter Time to Full Preterm Feeding Using Intact Protein Formula: A Randomized Controlled Trial
title_sort shorter time to full preterm feeding using intact protein formula: a randomized controlled trial
publisher MDPI AG
series International Journal of Environmental Research and Public Health
issn 1660-4601
publishDate 2019-08-01
description 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 (&#8805;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 &#8805;75% enteral intake from study formula (subset). Mothers were encouraged to provide their breast milk. Results: Of the 65 enrolled (IPF: <i>n</i> = 32; EHF: <i>n</i> = 33), 60 completed study feeding per protocol (IPF: <i>n</i> = 30; EHF: <i>n</i> = 30), 37 (62%) received predominantly breast milk, and 23 (38%) received &#8805;75% study formula intake (IPF: <i>n</i> = 11; EHF: <i>n</i> = 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, <i>p</i> &lt; 0.05) (subset analysis). Mean enteral intake significantly increased by day 14 for the IPF group (<i>p</i> &lt; 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.
topic infant
premature
infant formula
enteral nutrition
url https://www.mdpi.com/1660-4601/16/16/2911
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