Effects of Infant Formula With Human Milk Oligosaccharides on Growth and Morbidity: A Randomized Multicenter Trial.
J Pediatr Gastroenterol Nutr
; 64(4): 624-631, 2017 04.
Article
em En
| MEDLINE
| ID: mdl-28107288
ABSTRACT
OBJECTIVES:
The aim of the study was to evaluate the effects of infant formula supplemented with 2 human milk oligosaccharides (HMOs) on infant growth, tolerance, and morbidity.METHODS:
Healthy infants, 0 to 14 days old, were randomized to an intact-protein, cow's milk-based infant formula (control, nâ=â87) or the same formula with 1.0âg/L 2'fucosyllactose (2'FL) and 0.5âg/L lacto-N-neotetraose (LNnT) (test, nâ=â88) from enrollment to 6 months; all infants received standard follow-up formula without HMOs from 6 to 12 months. Primary endpoint was weight gain through 4 months. Secondary endpoints included additional anthropometric measures, gastrointestinal tolerance, behavioral patterns, and morbidity through age 12 months.RESULTS:
Weight gain was similar in both groups (mean difference [95% confidence interval] test vs control -0.30 [-1.94, 1.34] g/day; lower bound of 95% confidence interval was above noninferiority margin [-3âg/day]). Digestive symptoms and behavioral patterns were similar between groups; exceptions included softer stool (Pâ=â0.021) and fewer nighttime wake-ups (Pâ=â0.036) in the test group at 2 months. Infants receiving test (vs control) had significantly fewer parental reports (Pâ=â0.004-0.047) of bronchitis through 4 (2.3% vs 12.6%), 6 (6.8% vs 21.8%), and 12 months (10.2% vs 27.6%); lower respiratory tract infection (adverse event cluster) through 12 months (19.3% vs 34.5%); antipyretics use through 4 months (15.9% vs 29.9%); and antibiotics use through 6 (34.1% vs 49.4%) and 12 months (42.0% vs 60.9%).CONCLUSIONS:
Infant formula with 2'FL and LNnT is safe, well-tolerated, and supports age-appropriate growth. Secondary outcome findings showing associations between consuming HMO-supplemented formula and lower parent-reported morbidity (particularly bronchitis) and medication use (antipyretics and antibiotics) warrant confirmation in future studies.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Oligossacarídeos
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Infecções Respiratórias
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Aumento de Peso
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Fórmulas Infantis
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Leite Humano
Tipo de estudo:
Clinical_trials
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Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Animals
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Female
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Humans
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Infant
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Male
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Newborn
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article