TY - JOUR
T1 - Optimizing individual nutrition in preterm very low birth weight infants
T2 - double-blinded randomized controlled trial
AU - Brion, Luc P.
AU - Rosenfeld, Charles R.
AU - Heyne, Roy
AU - Brown, L. Steven
AU - Lair, Cheryl S.
AU - Petrosyan, Elen
AU - Jacob, Theresa
AU - Caraig, Maria
AU - Burchfield, Patti J.
N1 - Funding Information:
Acknowledgements This study was funded by the Gerber Foundation ($300,000) and in part by the CCRAC Award from the Children’s Foundation ($100,000). Cost of breast milk analyses included $58,000 for the equipment (purchase and 3-year maintenance and supplies) and $201,000 for salaries and fringes for 0.5 FTE of a dietitian 0.33 FTE for a formula technician. Jülide Sisman, MD, MS and LSB, MS, conducted blinded meetings of the data safety committee every 6 months to review safety, adverse events, and futility. Susan Chacko, RN, Maria DeLeon, and RN were research coordinators for part of this study. Chen Du, RD, Elizabeth Brammer, RD and Audrey Edwards, RD, dietitians at Parkland Hospital, obtained anthropometric measurements for this study and participated in patient recruitment, assessments of growth and laboratory
Funding Information:
results and recommendations for nutritional interventions. Christopher Clark, IT specialist at Parkland Hospital, extracted data from EPIC at Parkland. LaShunda Wilson, Kennissia Collins, and Brandon Hadnot (formula technicians at Parkland Hospital) measured human milk samples in both groups and supplemented milk in the experimental group. Blair Holbein, PhD, DCS helped with IRB approval of the NIRS measurements. Dr Holbein is supported by NCATS “National Center for Advancing Translational Sciences of the NIH” UL1TR001105. Preliminary results were submitted in abstract form: LPB, CRR, RH, LSB, CSL, and MC. Optimizing individual nutrition in preterm infants: randomized clinical trial (RCT). This abstract was presented at the Pediatric Academy Societies Meeting at Baltimore, MD, 4/29/19. LPB, CRR, RH, LSB, CSL, EP, TJ, MC, and PJB. Double-blinded randomized controlled trial (RCT) of Optimizing Individual Nutrition in Preterm (PT) very low birth weight infants: analysis of nutrient intake and growth patterns. Submitted for presentation at PAS, Phi-ladelphia, PA, May 2020.
Funding Information:
Funding This study was supported by a National Grant from the Gerber Foundation (LPB), the George L. MacGregor Professorship (CRR) and the following grant: Children’s Medical Center Clinical Advisory Committee (CCRAC)—Senior Investigator Research Award—New Direction (LPB, 2015−17). The funding organizations had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review and approval of the manuscript, and decision to submit the manuscript for publication.
Publisher Copyright:
© 2020, The Author(s), under exclusive licence to Springer Nature America, Inc.
PY - 2020/4/1
Y1 - 2020/4/1
N2 - Objective: In preterm neonates fed human milk, fortification may be adjusted by (1) optimization, based on growth rate and serum nutrient analyses, or (2) individualization, based on serial milk nutrient analyses. The primary aim was to determine whether individualized plus optimized nutrition (experimental) improves velocity of weight gain and linear growth from birth to endpoint (36 weeks postmenstrual age or discharge) when compared with optimized nutrition alone (controls). Study design: Double-blinded parallel group randomized trial in 120 neonates <29 weeks gestational age (GA) or <35 weeks and small for GA (birth weight < 10th centile). Result: Weight-gain velocity (13.1 ± 2.1, n = 57 controls, vs. 13.0 ± 2.6 g kg−1 day−1, n = 59 experimental, P = 0.87), linear growth (0.9 ± 0.2, n = 55, vs. 0.9 ± 0.2 cm week−1, n = 52, P = 0.90) and frequency of weight/length disproportion (2% vs. 2%, P = 0.98) were similar in both groups. Conclusions: Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.
AB - Objective: In preterm neonates fed human milk, fortification may be adjusted by (1) optimization, based on growth rate and serum nutrient analyses, or (2) individualization, based on serial milk nutrient analyses. The primary aim was to determine whether individualized plus optimized nutrition (experimental) improves velocity of weight gain and linear growth from birth to endpoint (36 weeks postmenstrual age or discharge) when compared with optimized nutrition alone (controls). Study design: Double-blinded parallel group randomized trial in 120 neonates <29 weeks gestational age (GA) or <35 weeks and small for GA (birth weight < 10th centile). Result: Weight-gain velocity (13.1 ± 2.1, n = 57 controls, vs. 13.0 ± 2.6 g kg−1 day−1, n = 59 experimental, P = 0.87), linear growth (0.9 ± 0.2, n = 55, vs. 0.9 ± 0.2 cm week−1, n = 52, P = 0.90) and frequency of weight/length disproportion (2% vs. 2%, P = 0.98) were similar in both groups. Conclusions: Individualized plus optimized nutrition does not improve weight gain, linear growth, or weight/length disproportion at endpoint versus optimized nutrition alone.
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U2 - 10.1038/s41372-020-0609-1
DO - 10.1038/s41372-020-0609-1
M3 - Article
C2 - 32071367
AN - SCOPUS:85079813043
SN - 0743-8346
VL - 40
SP - 655
EP - 665
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 4
ER -