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1.
BMC Pediatr ; 22(1): 580, 2022 10 07.
Artigo em Inglês | MEDLINE | ID: mdl-36207675

RESUMO

BACKGROUND: Our aim was to evaluate infant behavioral state, stool microbiome profile and calprotectin in infants with infantile colic receiving a partially hydrolyzed protein formula with or without added Lacticaseibacillus (formerly Lactobacillus) rhamnosus GG (LGG). METHODS: In this single-center, double-blind, controlled, parallel, prospective study, term infants (14-28 days of age) identified with colic (using modified Wessel's criteria: cried and/or fussed ≥ 3 h/day for ≥ 3 days/week, in a one-week period) were randomized to receive one of two formulas over a three-week feeding period: marketed partially hydrolyzed cow's milk-based infant formula (PHF, n = 35) or a similar formula with added LGG (PHF-LGG, n = 36). Parent-reported infant behavior was recorded at three time points (Study Days 2-4, 10-12, and 18-20). Duration (hours/day) of crying/fussing (averaged over each three-day period) was the primary outcome. Stool samples were collected at Baseline and Study End (Days 19-21) to determine stool LGG colonization (by qPCR) and microbial abundance (using 16S rRNA gene sequencing) and calprotectin (µg/g). RESULTS: Duration of crying/fussing (mean ± SE) decreased and awake/content behavior increased over time with no significant group differences over the course of the study. There were no group differences in the percentage of infants who experienced colic by study end. Colic decreased by Study End vs Baseline in both groups. Change in fecal calprotectin also was similar between groups. Comparing Study End vs Baseline, LGG abundance was greater in the PHF-LGG group (P < 0.001) whereas alpha diversity was greater in the PHF group (P = 0.022). Beta diversity was significantly different between PHF and PHF-LGG at Study End (P = 0.05). By study end, relative abundance of L. rhamnosus was higher in the PHF-LGG vs PHF group and vs Baseline. CONCLUSIONS: In this pilot study of infants with colic, both study formulas were well tolerated. Crying/fussing decreased and awake/content behavior increased in both study groups over the course of the study. Study results demonstrate a successful introduction of the probiotic to the microbiome. The partially hydrolyzed protein formula with added LGG was associated with significant changes in the gut microbiome. TRIAL REGISTRATION: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT02340143 . Registered 16/01/2015.


Assuntos
Cólica , Microbioma Gastrointestinal , Lacticaseibacillus rhamnosus , Probióticos , Animais , Bovinos , Método Duplo-Cego , Feminino , Humanos , Fórmulas Infantis , Recém-Nascido , Complexo Antígeno L1 Leucocitário , Projetos Piloto , Estudos Prospectivos , RNA Ribossômico 16S
2.
Curr Dev Nutr ; 5(5): nzab027, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33981943

RESUMO

BACKGROUND: Milk fat globule membrane (MFGM) and lactoferrin (LF) are human-milk bioactive components demonstrated to support gastrointestinal and immune development. Significantly fewer diarrhea and respiratory-associated adverse events through 18 mo of age were previously reported in healthy term infants fed a cow-milk-based infant formula with an added source of bovine MFGM and bovine LF through 12 mo of age. OBJECTIVES: The aim was to compare microbiota and metabolite profiles in a subset of study participants. METHODS: Stool samples were collected at baseline (10-14 d of age) and day 120. Bacterial community profiling was performed via 16S rRNA gene sequencing and alpha and beta diversity were analyzed (QIIME 2). Differentially abundant taxa were determined using linear discriminant analysis effect size (LefSE) and visualized (Metacoder). Untargeted stool metabolites were analyzed (HPLC/MS) and expressed as the fold-change between group means (control to MFGM+LF ratio). RESULTS: Alpha diversity increased significantly in both groups from baseline to 4 mo. Subtle group differences in beta diversity were demonstrated at 4 mo (Jaccard distance; R 2 = 0.01, P = 0.042). Specifically, Bacteroides uniformis and Bacteroides plebeius were more abundant in the MFGM+LF group at 4 mo. Metabolite profile differences for MFGM+LF versus control included lower fecal medium-chain fatty acids, deoxycarnitine, and glycochenodeoxycholate, and some higher fecal carbohydrates and steroids (P < 0.05). After applying multiple test correction, the differences in stool metabolomics were not significant. CONCLUSIONS: Addition of bovine MFGM and LF in infant formula was associated with subtle differences in stool microbiome and metabolome by 4 mo of age, including increased prevalence of Bacteroides species. Stool metabolite profiles may be consistent with altered microbial metabolism. This trial was registered at https://clinicaltrials.gov as NCT02274883.

3.
Nurse Pract ; 46(2): 19-26, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33399334

RESUMO

ABSTRACT: Nonalcoholic fatty liver disease (NAFLD), a multisystem, prevalent liver disease, can be managed with lifestyle interventions, including diet, given the lack of well-established pharmacologic therapies. This review explores the different dietary approaches that have been found effective in the management of NAFLD, offering a unique resource to healthcare professionals.


Assuntos
Hepatopatia Gordurosa não Alcoólica , Dieta , Humanos , Estilo de Vida , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/terapia
4.
Pediatr Res ; 89(5): 1222-1231, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-32615579

RESUMO

BACKGROUND: Few studies have evaluated nutritive effects of prebiotics on infant behavior state, physiology, or metabolic status. METHODS: In this double-blind randomized study, infants (n = 161) received cow's milk-based infant formula (Control) or similar formula with an added prebiotic blend (polydextrose and galactooligosaccharides [PDX/GOS]) from 14-35 to 112 days of age. Infant wake behavior (crying/fussing, awake/content) and 24-h sleep-wake actograms were analyzed (Baseline, Days 70 and 112). Salivary cortisol was immunoassayed (Days 70 and 112). In a subset, exploratory stool 16S ribosomal RNA-sequencing was analyzed (Baseline, Day 112). RESULTS: One hundred and thirty-one infants completed the study. Average duration of crying/fussing episodes was similar at Baseline, significantly shorter for PDX/GOS vs. Control at Day 70, and the trajectory continued at Day 112. Latency to first and second nap was significantly longer for PDX/GOS vs. Control at Day 112. Cortisol awakening response was demonstrated at Days 70 and 112. Significant stool microbiome beta-diversity and individual taxa abundance differences were observed in the PDX/GOS group. CONCLUSIONS: Results indicate faster consolidation of daytime waking state in infants receiving prebiotics and support home-based actigraphy to assess early sleep-wake patterns. A prebiotic effect on wake organization is consistent with influence on the gut-brain axis and warrants further investigation. IMPACT: Few studies have evaluated nutritive effects of prebiotics on infant behavior state, cortisol awakening response, sleep-wake entrainment, and gut microbiome. Faster consolidation of daytime waking state was demonstrated in infants receiving a prebiotic blend in infant formula through ~4 months of age. Shorter episodes of crying were demonstrated at ~2 months of age (time point corresponding to age/developmental range associated with peak crying) in infants receiving formula with added prebiotics. Results support home-based actigraphy as a suitable method to assess early sleep-wake patterns. Prebiotic effect on wake organization is consistent with influence on the gut-brain axis and warrants further investigation.


Assuntos
Leite/química , Sono , Vigília , Actigrafia , Animais , Eixo Encéfalo-Intestino , Bovinos , Método Duplo-Cego , Fezes , Feminino , Galactose/análise , Microbioma Gastrointestinal , Glucanos/química , Humanos , Hidrocortisona/metabolismo , Lactente , Fórmulas Infantis , Recém-Nascido , Masculino , Oligossacarídeos/química , Prebióticos , Estudos Prospectivos , Saliva/metabolismo
5.
J Pediatr ; 232: 23-30.e1, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33358843

RESUMO

OBJECTIVE: To determine feasibility of providing a concentrated emulsified long-chain polyunsaturated fatty acids (LCPUFA) supplement to very low birth weight infants, and to evaluate blood LCPUFA concentrations at 2 and 8 weeks of study supplementation. STUDY DESIGN: This prospective, randomized, double-blind, placebo-controlled trial randomized infants to receive (1) LCPUFA-120 (a supplement of 40 mg/kg/day docosahexaenoic acid [DHA] and 80 mg/kg/day arachidonic acid [ARA]; DHA:ARA at 1:2 ratio), (2) LCPUFA-360 (a supplement of 120 mg/kg/day DHA and 240 mg/kg/day ARA), or (3) sunflower oil (placebo control). Infants received supplement daily for 8 weeks or until discharge, whichever came first. Whole blood LCPUFA levels (wt%; g/100 g) were measured at baseline, 2 weeks, and 8 weeks. RESULTS: Infants were 28 weeks of gestation (IQR, 27-30 weeks of gestation) and weighed 1040 g (IQR, 910-1245 g). At 2 weeks, the change in blood DHA (wt%) from baseline differed significantly among groups (sunflower oil, n = 6; -0.63 [IQR, -0.96 to -0.55]; LCPUFA-120: n = 12; -0.14 [IQR, -0.72 to -0.26]; LCPUFA-360, n = 12; 0.46 [IQR, 0.17-0.81]; P = .002 across groups). Change in blood ARA (wt%) also differed by group (sunflower oil: -2.2 [IQR, -3.9 to -1.7]; LCPUFA-120: 0.1 [IQR, -2.1 to 1.1] vs LCPUFA-360: 2.9 IQR, 1.5 to 4.5]; P = .0002). Change from baseline to 8 weeks significantly differed between groups for DHA (P = .02) and ARA (P = .003). CONCLUSIONS: Enteral LCPUFA supplementation supported higher blood DHA by 2 weeks. LCPUFA supplementation at 360 mg of combined DHA and ARA is likely necessary to reduce declines as well as allow increases in whole blood concentrations in the first 8 weeks of life. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03192839.


Assuntos
Ácido Araquidônico/administração & dosagem , Suplementos Nutricionais , Ácidos Docosa-Hexaenoicos/administração & dosagem , Nutrição Enteral , Recém-Nascido de muito Baixo Peso , Ácido Araquidônico/sangue , Ácidos Docosa-Hexaenoicos/sangue , Método Duplo-Cego , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Estudos Prospectivos
6.
J Pediatr ; 215: 24-31.e8, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31668885

RESUMO

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 receiving formula 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.


Assuntos
Desenvolvimento Infantil/fisiologia , Cognição/fisiologia , Glicolipídeos/farmacologia , Glicoproteínas/farmacologia , Fórmulas Infantis/química , Lactoferrina/farmacologia , Leite , Transtornos do Neurodesenvolvimento/prevenção & controle , Animais , Pré-Escolar , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Gotículas Lipídicas , Masculino , Transtornos do Neurodesenvolvimento/fisiopatologia , Transtornos do Neurodesenvolvimento/psicologia , Prognóstico , Valores de Referência , Estudos Retrospectivos
7.
Artigo em Inglês | MEDLINE | ID: mdl-27914519

RESUMO

Docosahexaenoic acid (DHA) in infant formula at concentrations based on worldwide human milk has resulted in circulating red blood cell (RBC) lipids related to visual and cognitive development. In this study, infants received study formula (17mg DHA/100kcal) with a commercially-available (Control: n=140; DHASCO®) or alternative (DHASCO®-B: n=127) DHA single cell oil from 14 to 120 days of age. No significant group differences were detected for growth rates by gender through 120 days of age. Blood fatty acids at 120 days of age were assessed by capillary column gas chromatography in a participant subset (Control: n=34; DHASCO-B: n=27). The 90% confidence interval (91-104%) for the group mean (geometric) total RBC DHA (µg/mL) ratio fell within the pre-specified equivalence limit (80-125%), establishing study formula equivalence with respect to DHA. This study demonstrated infant formula with DHASCO-B was safe, well-tolerated, and associated with normal growth. Furthermore, DHASCO and DHASCO-B represented equivalent sources of DHA as measured by circulating RBC DHA.


Assuntos
Desenvolvimento Infantil/fisiologia , Ácidos Docosa-Hexaenoicos/sangue , Fórmulas Infantis/química , Eletrocromatografia Capilar , Método Duplo-Cego , Ácidos Graxos/análise , Ácidos Graxos/sangue , Feminino , Idade Gestacional , Humanos , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido , Masculino , Estudos Prospectivos
9.
J Pediatr ; 162(3 Suppl): S101-6, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23445840

RESUMO

Designing an optimal feeding program for preterm infants is particularly challenging. These infants require individualized feeding plans and frequent medical interventions, and their health status and physical limitations necessitate specialized products. This review highlights the challenges of translating new understandings into practical application and, specifically, the challenges of translating scientific knowledge into available nutritional products that can be used to meet the special needs of preterm infants. All infant formula products are developed for use in a heavily regulated environment, which is not integrated internationally. The regulatory framework for preterm nutrition products can be particularly complex in the areas of composition and the degree of scientific and clinical support required across countries. Registration and approval of products for preterm infants in most countries must address the complexities for a population for which no well-recognized nonclinical safety or efficacy models exist. Mandatory regulatory review for science-based innovative product improvements may require two or more years. In addition, throughout years of development, industry must justify the financial support of programs that serve a small specialty segment of the market. These industry-specific challenges may be neither visible nor appreciated by the general public or health care professionals, and, yet, they are integral to the development process. Effective collaborations among academic scientists, regulatory authorities, and the industry are essential to bring science to the bedside. Without such collaborations, preterm infants, and particularly very low birth weight infants, in the neonatal intensive care unit will not be able to benefit from innovative nutrition interventions designed to improve short- and long-term clinical outcomes.


Assuntos
Qualidade dos Alimentos , Cuidado do Lactente , Fórmulas Infantis , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido Prematuro/fisiologia , Ensaios Clínicos como Assunto , Qualidade de Produtos para o Consumidor/legislação & jurisprudência , Qualidade de Produtos para o Consumidor/normas , Comportamento Cooperativo , Saúde Global , Regulamentação Governamental , Humanos , Cuidado do Lactente/métodos , Cuidado do Lactente/normas , Fórmulas Infantis/legislação & jurisprudência , Fórmulas Infantis/normas , Recém-Nascido , Internacionalidade , Pesquisa Translacional Biomédica
11.
Pediatrics ; 130(4): e928-35, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22987877

RESUMO

OBJECTIVES: To evaluate the growth, tolerance, and safety of a new ultraconcentrated liquid human milk fortifier (LHMF) designed to provide optimal nutrients for preterm infants receiving human breast milk in a safe, nonpowder formulation. METHODS: Preterm infants with a body weight ≤ 1250 g fed expressed and/or donor breast milk were randomized to receive a control powder human milk fortifier (HMF) or a new LHMF for 28 days. When added to breast milk, the LHMF provided ∼20% more protein than the control HMF. Weight, length, head circumference, and serum prealbumin, albumin, blood urea nitrogen, electrolytes, and blood gases were measured. The occurrence of sepsis, necrotizing enterocolitis, and serious adverse events were monitored. RESULTS: This multicenter, third party-blinded, randomized controlled, prospective study enrolled 150 infants. Achieved weight and linear growth rate were significantly higher in the LHMF versus control groups (P = .04 and 0.03, respectively). Among infants who adhered closely to the protocol, the LHMF had a significantly higher achieved weight, length, head circumference, and linear growth rate than the control HMF (P = .004, P = .003, P = .04, and P = .01, respectively). There were no differences in measures of feeding tolerance or days to achieve full feeding volumes. Prealbumin, albumin, and blood urea nitrogen were higher in the LHMF group versus the control group (all P < .05). There was no difference in the incidence of confirmed sepsis or necrotizing enterocolitis. CONCLUSIONS: Use of a new LHMF in preterm infants instead of powder HMF is safe. Benefits of LHMF include improvements in growth and avoidance of the use of powder products in the NICU.


Assuntos
Proteínas Alimentares , Nutrição Enteral/métodos , Alimentos Fortificados , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido Prematuro/crescimento & desenvolvimento , Leite Humano , Aumento de Peso , Estatura , Feminino , Cabeça/crescimento & desenvolvimento , Humanos , Recém-Nascido , Masculino , Estudos Prospectivos , Método Simples-Cego
12.
Nutr J ; 11: 38, 2012 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-22676715

RESUMO

BACKGROUND: To ensure the suitability of an infant formula as the sole source of nutrition or provide benefits similar to outcomes in breastfed infants, advancements in formula composition are warranted as more research detailing the nutrient composition of human milk becomes available. This study was designed to evaluate growth and tolerance in healthy infants who received one of two investigational cow's milk-based formulas with adjustments in carbohydrate, fat, and calcium content and supplemented with a prebiotic blend of polydextrose (PDX) and galactooligosaccharides (GOS) or GOS alone. METHODS: In this multi-center, double-blind, parallel-designed, gender-stratified prospective study 419 infants were randomized and consumed either a marketed routine cow's milk-based infant formula (Control; Enfamil® LIPIL®, Mead Johnson Nutrition, Evansville, IN) (n = 142) or one of two investigational formulas from 14 to 120 days of age. Investigational formulas were supplemented with 4 g/L (1:1 ratio) of a prebiotic blend of PDX and GOS (PDX/GOS; n = 139) or 4 g/L of GOS alone (GOS; n = 138). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age. Daily recall of formula intake, tolerance, and stool characteristics was collected during study weeks 1 and 2 and 24-h recall was collected at 60, 90, and 120 days of age. Medically-confirmed adverse events were recorded throughout the study. RESULTS: There were no group differences in growth rate from 14 to 120 days of age. Discontinuation rates were not significantly different among study groups. No differences in formula intake or infant fussiness or gassiness were observed. During study weeks 1 and 2 and at 60 days of age stool consistency ratings were higher (i.e. softer stools) for infants in the PDX/GOS and GOS groups versus Control and remained higher at 120 days for the PDX/GOS group (all P < 0.05). The overall incidence of medically-confirmed adverse events was similar among groups. CONCLUSIONS: Investigational routine infant formulas supplemented with 4 g/L of either a prebiotic blend of PDX and GOS or GOS alone were well-tolerated and supported normal growth. Compared to infants who received the unsupplemented control formula, infants who received prebiotic supplementation experienced a softer stooling pattern similar to that reported in breastfed infants. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00712608.


Assuntos
Suplementos Nutricionais , Glucanos/administração & dosagem , Fórmulas Infantis/química , Trissacarídeos/administração & dosagem , Animais , Método Duplo-Cego , Fezes/química , Feminino , Humanos , Lactente , Fórmulas Infantis/administração & dosagem , Masculino , Leite/química , Prebióticos/análise , Estudos Prospectivos
13.
J Pediatr ; 156(6): 902-906.e1, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20227721

RESUMO

OBJECTIVE: To investigate the incidence of allergic and respiratory diseases through age 3 years in children fed docosahexaenoic acid (DHA)- and arachidonic acid (ARA)-supplemented formula during infancy. STUDY DESIGN: Children who completed randomized, double-blind studies of DHA/ARA-supplemented (0.32%-0.36%/0.64%-0.72% of total fatty acids, respectively) versus nonsupplemented (control) formulas, fed during the first year of life, were eligible. Blinded study nurses reviewed medical charts for upper respiratory infection (URI), wheezing, asthma, bronchiolitis, bronchitis, allergic rhinitis, allergic conjunctivitis, otitis media, sinusitis, atopic dermatitis (AD), and urticaria. RESULTS: From the 2 original cohorts, 89/179 children participated; 38/89 were fed DHA/ARA formula. The DHA/ARA group had significantly lower odds for developing URI (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.08-0.58), wheezing/asthma (OR, 0.32; 95% CI, 0.11-0.97), wheezing/asthma/AD (OR, 0.25; 95% CI, 0.09-0.67), or any allergy (OR, 0.28; 95% CI, 0.10-0.72). The control group had significantly shorter time to first diagnosis of URI (P = .006), wheezing/asthma (P = .03), or any allergy (P = .006). CONCLUSIONS: DHA/ARA supplementation was associated with delayed onset and reduced incidence of URIs and common allergic diseases up to 3 years of age.


Assuntos
Ácidos Araquidônicos/administração & dosagem , Suplementos Nutricionais , Ácidos Docosa-Hexaenoicos/administração & dosagem , Hipersensibilidade/epidemiologia , Fórmulas Infantis , Doenças Respiratórias/epidemiologia , Idade de Início , Criança , Pré-Escolar , Feminino , Humanos , Hipersensibilidade/prevenção & controle , Lactente , Recém-Nascido , Masculino , Estado Nutricional , Doenças Respiratórias/prevenção & controle
14.
Nutr J ; 8: 27, 2009 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-19545360

RESUMO

BACKGROUND: Parents who perceive common infant behaviors as formula intolerance-related often switch formulas without consulting a health professional. Up to one-half of formula-fed infants experience a formula change during the first six months of life. METHODS: The objective of this study was to assess discontinuance due to study physician-assessed formula intolerance in healthy, term infants. Infants (335) were randomized to receive either a standard intact cow milk protein formula (INTACT) or a partially hydrolyzed cow milk protein formula (PH) in a 60 day non-inferiority trial. Discontinuance due to study physician-assessed formula intolerance was the primary outcome. Secondary outcomes included number of infants who discontinued for any reason, including parent-assessed. RESULTS: Formula intolerance between groups (INTACT, 12.3% vs. PH, 13.7%) was similar for infants who completed the study or discontinued due to study physician-assessed formula intolerance. Overall study discontinuance based on parent- vs. study physician-assessed intolerance for all infants (14.4 vs.11.1%) was significantly different (P = 0.001). CONCLUSION: This study demonstrated no difference in infant tolerance of intact vs. partially hydrolyzed cow milk protein formulas for healthy, term infants over a 60-day feeding trial, suggesting nonstandard partially hydrolyzed formulas are not necessary as a first-choice for healthy infants. Parents frequently perceived infant behavior as formula intolerance, paralleling previous reports of unnecessary formula changes. TRIAL REGISTRATION: clinicaltrials.gov: NCT00666120.


Assuntos
Fórmulas Infantis/administração & dosagem , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido , Hidrolisados de Proteína/administração & dosagem , Humanos , Comportamento do Lactente , Hipersensibilidade a Leite , Pais , Percepção
15.
Clin Pediatr (Phila) ; 48(1): 58-65, 2009 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-18832532

RESUMO

Very fussy or extremely fussy infants were randomized to receive: soy-based formula (Soy: n = 82) or a partially hydrolyzed cow's milk protein (CMP), low-lactose formula (PHF: n = 77) in a multicenter, double-blind, randomized, parallel, prospective 28-day feeding trial. Body weight and infant formula tolerance were reported. Adverse events were recorded throughout the study. A significant reduction in mean scores of fussiness, gas, spit-up, and crying compared with baseline measures was observed in infants who received either Soy or PHF within 1 day of formula intake; improvement in symptoms was sustained by study end. Stool consistency remained constant through day 28 in the PHF group, whereas stools in the Soy group became more firm by day 2 and did not return to prestudy consistency. PHF, with a protein profile patterned more closely on human breast milk, improved symptoms of formula intolerance as well as soy-based formula.


Assuntos
Fórmulas Infantis , Método Duplo-Cego , Fezes , Humanos , Lactente , Comportamento do Lactente , Lactose , Proteínas do Leite , Estudos Prospectivos , Leite de Soja
16.
J Pediatr ; 153(2): 266-71, 2008 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-18534230

RESUMO

OBJECTIVE: In study 1, to compare the effect on growth in healthy infants of a new amino acid-based formula (AAF) and a control extensively hydrolyzed formula (EHF), with both docosahexaenoic acid (DHA) and arachidonic acid (ARA) at levels similar to those in human milk worldwide. In study 2, to evaluate the hypoallergenicity of this new AAF in infants and children with confirmed cow's milk allergy (CMA). STUDY DESIGN: In study 1, a total of 165 healthy, full-term, formula-fed infants randomly received the new AAF or control formula. Anthropometric measurements, tolerance, and adverse events were recorded throughout the study. Plasma amino acid profiles were evaluated in a subset of the infants. In study 2, the hypoallergenicity of the new AAF was evaluated in 32 infants and children using a double-blind, placebo-controlled food challenge; an open challenge; and a 7-day feeding. RESULTS: In study 1, overall growth, tolerance, and safety outcomes were similar in both groups. In study 2, 29 of the 32 subjects completed both challenges; no allergic reaction was seen in any of the 32 subjects. CONCLUSIONS: The new AAF with DHA and ARA at levels similar to those in human milk worldwide is hypoallergenic. It also is safe and supports growth in healthy, term infants.


Assuntos
Aminoácidos/administração & dosagem , Ácido Araquidônico/administração & dosagem , Ácidos Docosa-Hexaenoicos/administração & dosagem , Fórmulas Infantis/administração & dosagem , Hipersensibilidade a Leite/dietoterapia , Animais , Criança , Pré-Escolar , Suplementos Nutricionais , Método Duplo-Cego , Feminino , Crescimento/efeitos dos fármacos , Humanos , Lactente , Alimentos Infantis/efeitos adversos , Recém-Nascido , Masculino , Leite/efeitos adversos , Hipersensibilidade a Leite/etiologia , Estudos Prospectivos , Resultado do Tratamento
17.
J Pediatr Gastroenterol Nutr ; 44(3): 359-64, 2007 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-17325558

RESUMO

OBJECTIVES: The present study was designed to evaluate the effect of 2 different combinations of prebiotic ingredients, polydextrose (PDX), galactooligosaccharides (GOS), and lactulose (LOS), at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age. PATIENTS AND METHODS: Healthy, formula-fed, term infants (n = 226) were randomly assigned to 1 of 3 study formula groups: control group (n = 76), PG4 group (control formula supplemented with 4 g/L of a prebiotic blend, n = 74), or PGL8 group (control formula supplemented with 8 g/L of a prebiotic blend, n = 76). Anthropometric measurements were taken at 14, 30, 60, 90, and 120 days of age, and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30, 60, 90, and 120 days of age. Adverse events were recorded throughout the study. RESULTS: There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point. Significant differences in stool consistency were detected among the 3 formula groups at 30, 60, and 90 days of age (P < 0.001, P = 0.025, P = 0.004, respectively), with the supplemented formula groups having looser stools than the control group. The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age (P = 0.021 and P = 0.017, respectively), but all of the groups were similar at 60, 90, and 120 days of age. A statistical difference was detected among the formula groups in 3 categories of adverse events: diarrhea (control vs PG4, 4% vs 18%, P = 0.008), eczema (PG4 vs control, 18% vs 7%, P = 0.046; PG4 vs PGL8, 18% vs 4%, P = 0.008), and irritability (control vs PGL8, 4% vs 16%, P = 0.027). CONCLUSIONS: Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula. A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics.


Assuntos
Desenvolvimento Infantil , Fezes/microbiologia , Fórmulas Infantis , Probióticos/administração & dosagem , Antropometria , Aleitamento Materno , Ciências da Nutrição Infantil , Método Duplo-Cego , Feminino , Aditivos Alimentares/administração & dosagem , Glucanos/administração & dosagem , Humanos , Lactente , Recém-Nascido , Lactulose/administração & dosagem , Masculino , Oligossacarídeos/administração & dosagem , Estudos Prospectivos , Nascimento a Termo
18.
J Pediatr Gastroenterol Nutr ; 42(3): 287-92, 2006 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-16540798

RESUMO

OBJECTIVES: A randomized, double-blind, prospective trial assessed effects of different formula levels of polyunsaturated fatty acids on blood phospholipid docosahexaenoic (DHA; 22:6omega3) and arachidonic acids (ARA; 20:4omega6) in term infants at 120 days of age. METHODS: Healthy, formula-fed term infants (n = 78) were randomized to 1) routine milk-based formula with 8 mg DHA, 21 mg ARA, 110 mg alpha-linolenic (ALA; 18:3omega3), and 1,000 mg linoleic acids (LA; 18:2omega6) per 100 kcal (Lower-long-chain polyunsaturated fatty acids [LCPUFA]; n = 39) or 2) routine milk-based formula with 17 mg DHA, 34 mg ARA, 85 mg ALA, and 860 mg LA per 100 kcal (Higher-LCPUFA; n = 39). Fatty acid methyl esters from red blood cell (RBC) and plasma phospholipid fractions were assessed using capillary column gas chromatography. RESULTS: Compared with infants fed Lower-LCPUFA formula, the Higher-LCPUFA group had significantly greater percentages of fatty acids as DHA in RBC phosphatidylethanolamine (PE), RBC phosphatidylcholine (PC), total RBC, and plasma phospholipids (P < 0.001). Infants fed Lower-LCPUFA formula had higher percentages of precursor omega6 fatty acids in the desaturation/elongation pathway but lower percentages of ARA (RBC PE, RBC PC, and plasma phospholipid, P < 0.001; total RBC, P = 0.017) compared with the Higher-LCPUFA group. CONCLUSIONS: Greater amounts of dietary ALA do not produce as great an increase in DHA in blood lipids as preformed dietary DHA. Infants fed DHA at levels similar to human milk had significantly greater percentage of DHAat 120 days of age compared with the Lower-LCPUFA group despite higher precursor levels of ALA.


Assuntos
Gorduras Insaturadas na Dieta/metabolismo , Ácidos Docosa-Hexaenoicos/metabolismo , Eritrócitos/química , Fórmulas Infantis/química , Fenômenos Fisiológicos da Nutrição do Lactente , Ácido Araquidônico/administração & dosagem , Ácido Araquidônico/sangue , Ácido Araquidônico/metabolismo , Cromatografia Gasosa/métodos , Gorduras Insaturadas na Dieta/administração & dosagem , Gorduras Insaturadas na Dieta/sangue , Ácidos Docosa-Hexaenoicos/administração & dosagem , Ácidos Docosa-Hexaenoicos/sangue , Método Duplo-Cego , Feminino , Alimentos Fortificados , Humanos , Lactente , Recém-Nascido , Ácido Linoleico/administração & dosagem , Ácido Linoleico/sangue , Ácido Linoleico/metabolismo , Masculino , Estudos Prospectivos , Ácido alfa-Linolênico/administração & dosagem , Ácido alfa-Linolênico/sangue , Ácido alfa-Linolênico/metabolismo
19.
J Am Diet Assoc ; 105(10): 1567-72, 2005 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-16183356

RESUMO

OBJECTIVE: To evaluate the growth of resident aerobic mesophilic flora and added Enterobacter sakazakii in fresh, unfortified human milk; fresh human milk fortified with two commercial powdered fortifiers differing in iron content; and infant formula prepared from powder. SUBJECTS: Eight mothers provided preterm breast milk samples. METHODS: Breast milk samples were divided into three aliquots: unfortified, fortified with fortifier containing 1.44 mg iron/14 kcal, and fortified with fortifier containing 0.4 mg iron/14 kcal. Aliquots of formula were prepared. Breast milk and formula aliquots were divided into two test samples. Half were inoculated with low amounts of E sakazakii; half were not. All test samples were maintained at room temperature (22 degrees C), serially diluted, and plated onto agars after 0, 2, 4, and 6 hours. Plates were incubated at 35 degrees C and enumerated. STATISTICAL ANALYSES: Data were analyzed using repeated measures analysis of variance. P<.05 was considered significant. RESULTS: There were no differences in colony counts of aerobic bacteria among uninoculated or among inoculated human milk samples at any time; counts did not increase significantly over 6 hours. There were no differences in colony counts of E sakazakii among inoculated human milk samples at any time; counts did not increase significantly over 6 hours. Aerobic bacteria and E sakazakii colony counts from infant formula did not increase significantly over 6 hours. CONCLUSIONS: During 6 hours at 22 degrees C, fresh human milk and formula had negligible bacterial growth; fortifying human milk with powdered fortifiers did not affect bacterial growth.


Assuntos
Cronobacter sakazakii/crescimento & desenvolvimento , Contaminação de Alimentos/análise , Alimentos Fortificados , Ferro da Dieta/administração & dosagem , Leite Humano/microbiologia , Análise de Variância , Contagem de Colônia Microbiana , Qualidade de Produtos para o Consumidor , Cronobacter sakazakii/metabolismo , Relação Dose-Resposta a Droga , Microbiologia de Alimentos , Humanos , Fórmulas Infantis/normas , Temperatura , Fatores de Tempo
20.
J Pediatr Gastroenterol Nutr ; 41(3): 347-50, 2005 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-16131992

RESUMO

OBJECTIVES: Feeding difficulties are common among survivors of extracorporeal membrane oxygenation (ECMO). In this study, we characterized antroduodenal motor patterns and feeding outcomes among 10 ECMO survivors. METHODS: Intestinal motor patterns were recorded in 10 ECMO survivors within 48 hours of the initiation of enteral feeding. Subsequent feeding outcomes were tracked until discharge. We compared the motor patterns of infants achieving full oral feedings by 1 month postnatal age with those who did not achieve full oral feedings by 1 month postnatal age. RESULTS: In infants failing to achieve full oral feedings, duodenal clusters occupied less of the total record (P < 0.05), and clusters had significantly lower amplitude (P < 0.05) than were seen in successful infants. Infants failing to achieve full oral feedings had greater time spent in motor quiescence (P < 0.05) than successful infants. Neither group had migrating motor complexes during fasting or mature duodenal motor responses to feeding. At discharge, six infants with feeding failure were more likely to require tube feeding, and the hospital stay was 3.6 times longer. Intracranial abnormalities were detected by computed tomography scan in five of six infants with feeding failure. CONCLUSIONS: Early intestinal dysmotility in infants surviving ECMO is associated with later feeding difficulties and prolonged hospitalization.


Assuntos
Nutrição Enteral , Oxigenação por Membrana Extracorpórea/efeitos adversos , Motilidade Gastrointestinal/fisiologia , Doenças do Recém-Nascido/fisiopatologia , Envelhecimento/fisiologia , Encéfalo/anormalidades , Encéfalo/diagnóstico por imagem , Duodeno/fisiologia , Comportamento Alimentar/fisiologia , Feminino , Humanos , Alimentos Infantis , Recém-Nascido , Doenças do Recém-Nascido/terapia , Recém-Nascido Prematuro/fisiologia , Tempo de Internação , Masculino , Manometria , Estudos Prospectivos , Antro Pilórico/fisiologia , Radiografia
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