Fei Li1, Steven S Wu2, Carol Lynn Berseth3, Cheryl L Harris4, James D Richards5, Jennifer L Wampler4, Weihong Zhuang4, Geoffrey Cleghorn6, Colin D Rudolph7, Bryan Liu8, D Jill Shaddy9, John Colombo9. 1. Departments of Developmental and Behavioral Pediatrics & Child Primary Care, MOE-Shanghai Key Lab for Children's Environmental Health, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine, Shanghai, China. 2. Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN. Electronic address: Steven.Wu2@rb.com. 3. Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; Medical and Scientific Affairs, Brightseed, San Francisco, California. 4. Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN. 5. Nutrition Science, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; DSM Nutritional Products, Parsippany, New Jersey. 6. Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; Faculty of Health, Queensland University of Technology, Brisbane, Australia. 7. Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; Department of Pediatrics, University of California, San Francisco, CA. 8. Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, Evansville, IN; College of Biotechnology, East China University of Science and Technology, Shanghai, China. 9. Schiefelbusch Institute for Life Span Studies, University of Kansas, Lawrence, KS.
Abstract
OBJECTIVE: To evaluate neurodevelopment, growth, and health outcomes in infants receiving bovine milk fat globule membrane (MFGM) and lactoferrin in infant formula. STUDY DESIGN:Healthy term infants were randomized to a cow's milk-based infant formula or MFGM + LF (a similar infant formula, with an added source of bovine milk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5 g/L] and bovine lactoferrin [0.6 g/L]) through 365 days of age. The Bayley Scales of Infant Development, 3rd edition cognitive composite score at day 365 was the primary outcome. Secondary outcomes included tolerance measures through day 365, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events through day 545. RESULTS: Of 451 infants enrolled (control, 228; MFGM + LF, 223), 291 completed study feeding and Bayley-III testing at day 365 (control, 148; MFGM + LF, 143). The mean cognitive (+8.7), language (+12.3), and motor (+12.6) scores were higher (P < .001) for the MFGM + LF group; no differences were observed at day 545. Global development scores from day 120 to day 275 and attention at day 365 were significantly improved. Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P < .05) in the MFGM + LF group. The overall incidence of respiratory-associated adverse events and diarrhea were significantly lower for the MFGM + LF group through day 545. CONCLUSIONS:Infants receivingformula with added bovine MFGM and bovine lactoferrin had an accelerated neurodevelopmental profile at day 365 and improved language subcategories at day 545. Formulas were associated with age-appropriate growth and significantly fewer diarrhea and respiratory-associated adverse events through 545 days of age. TRIAL REGISTRATION CLINICALTRIALS.GOV:: NCT02274883.
RCT Entities:
OBJECTIVE: To evaluate neurodevelopment, growth, and health outcomes in infants receiving bovinemilk fat globule membrane (MFGM) and lactoferrin in infant formula. STUDY DESIGN: Healthy term infants were randomized to a cow's milk-based infant formula or MFGM + LF (a similar infant formula, with an added source of bovinemilk fat globule membrane [bMFGM; whey protein-lipid concentrate, 5 g/L] and bovinelactoferrin [0.6 g/L]) through 365 days of age. The Bayley Scales of Infant Development, 3rd edition cognitive composite score at day 365 was the primary outcome. Secondary outcomes included tolerance measures through day 365, additional neurodevelopmental and language outcomes, growth, and medically confirmed adverse events through day 545. RESULTS: Of 451 infants enrolled (control, 228; MFGM + LF, 223), 291 completed study feeding and Bayley-III testing at day 365 (control, 148; MFGM + LF, 143). The mean cognitive (+8.7), language (+12.3), and motor (+12.6) scores were higher (P < .001) for the MFGM + LF group; no differences were observed at day 545. Global development scores from day 120 to day 275 and attention at day 365 were significantly improved. Few group differences in day 545 neurodevelopmental outcomes were detected, however scores of some subcategories of the MacArthur-Bates Communicative Development Inventories were higher (P < .05) in the MFGM + LF group. The overall incidence of respiratory-associated adverse events and diarrhea were significantly lower for the MFGM + LF group through day 545. CONCLUSIONS:Infants receiving formula with added bovineMFGM and bovinelactoferrin had an accelerated neurodevelopmental profile at day 365 and improved language subcategories at day 545. Formulas were associated with age-appropriate growth and significantly fewer diarrhea and respiratory-associated adverse events through 545 days of age. TRIAL REGISTRATION CLINICALTRIALS.GOV:: NCT02274883.
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