美国婴幼儿配方奶中新成分的安全性评估方法

婴幼儿处于生长发育极其迅速的关键时期。本文介绍美国现有婴儿配方奶粉新成分安全性评价方法中需要解决的关键问题，及相应的解决策略。     

Variation in Infant Formula Macronutrient Ingredients Is Associated with Infant Anthropometrics

Background: There is wide variation in the macronutrient ingredient base of infant formula. How variation in macronutrient ingredients may impact infant growth remains largely unknown. Methods: The 2015–2016 National Health and Nutrition Examination Survey (NHANES) dataset was utilized, including infant anthropometrics and dietary intake. The protein, fat, and carbohydrate sources of formulas consumed were assembled and considered as potential predictors in multivariable models of infant Z-scores among infants < 6 months, 6–12 months and all infants combined (0–12 months). Results: The following relationships represent ingredient covariates within the final multivariable models of infant Z-scores. Consuming formula with palm oil was associated with higher weight-for-length Z-scores among infants < 6 months, but lower weight-for-age and weight-for-length Z-scores among infants 6–12 months. Consuming soy-protein formulas was associated with lower weight-for-length, head circumference-for-age and abdominal circumference-for-age Z-scores among infants < 6 months. Consuming sucrose-containing formula was associated with higher weight-for-length and abdominal circumference-for-age Z-score among infants 0–12 months. Conclusions: These data provide proof-of-concept that all formulas are not the same. Variation in macronutrient ingredients within the standard formula category is associated with differences in infant anthropometric outcomes. Long-term and mechanistic studies are warranted to pursue these findings; especially for palm oil, soy protein, and sucrose.     

Novel Approaches to Improve the Intrinsic Microbiological Safety of Powdered Infant Milk Formula

Human milk is recognised as the best form of nutrition for infants. However; in instances where breast-feeding is not possible, unsuitable or inadequate, infant milk formulae are used as breast milk substitutes. These formulae are designed to provide infants with optimum nutrition for normal growth and development and are available in either powdered or liquid forms. Powdered infant formula is widely used for convenience and economic reasons. However; current manufacturing processes are not capable of producing a sterile powdered infant formula. Due to their immature immune systems and permeable gastro-intestinal tracts, infants can be more susceptible to infection via foodborne pathogenic bacteria than other age-groups. Consumption of powdered infant formula contaminated by pathogenic microbes can be a cause of serious illness. In this review paper, we discuss the current manufacturing practices present in the infant formula industry, the pathogens of greatest concern, Cronobacter and Salmonella and methods of improving the intrinsic safety of powdered infant formula via the addition of antimicrobials such as: bioactive peptides; organic acids; probiotics and prebiotics.     

Evaluation of the Safety of a Plant-Based Infant Formula Containing Almonds and Buckwheat in a Neonatal Piglet Model

A randomized neonatal piglet trial was conducted to evaluate the safety and the effects of a plant-based formula containing almonds and buckwheat as the main ingredients on growth and plasma parameters. From postnatal day (PND) 2 to 21, the piglets were fed a dairy-based milk formula (Similac Advance) or a plant-based formula (Else Nutrition) and all piglets were euthanized at day 21. No diarrhea was observed after PND 8 and all the piglets completed the trial. Body growth, kcal intake, the complete plasma count parameters and hematological parameters were within the reference range in both groups. Organ growth and development was similar between the two groups. Plasma glucose was higher in the dairy-based-fed piglets relative to the plant-based at 2 weeks of age. Liver function biomarkers levels were greater in the plasma of the plant-based compared to the dairy-based fed group. In addition, calcium levels were higher in the plant-based fed piglets at 1 week of age. Thus, the plant-based formula tested in this study was well tolerated by the piglets and supported similar growth compared to dairy-based milk formula. Therefore, the results support the safety of the tested plant-based infant formula during the neonatal period in comparison to the dairy-based formula fed group.     

Infant mortality, public policy and inequality – a comparison of 18 industrialised countries 1950–85

Using new comparative data bases this paper examines whether infant mortality rates in industrialised nations are affected by public policies and income inequality. Particular attention is given to the role of the level of economic development, public policy and the distribution of economic resources. The study shows that the level of economic development has a strong, but decreasing impact on the infant mortality rate. Income inequality and relative poverty rates appear to be of greater importance for the variation in infant mortality rates than the level of economic development between rich countries. Levels of unemployment and of social security benefits seems to affect the infant mortality rate; the combination of high unemployment and low unemployment benefits seems to be associated with particularly high mortality rates. A high level of family benefits is also associated with low infant mortality rates.     

Transient Effect of Infant Formula Supplementation on the Intestinal Microbiota

Breastfeeding is the gold standard for feeding infants because of its long-term benefits to health and development, but most infants in the United States are not exclusively breastfed in the first six months. We enrolled 24 infants who were either exclusively breastfed or supplemented with formula by the age of one month. We collected diet information, stool samples for evaluation of microbiotas by 16S rRNA sequencing, and blood samples for assessment of immune development by flow cytometry from birth to 6 months of age. We further typed the Bifidobacterium strains in stool samples whose 16S rRNA sequencing showed the presence of Bifidobacteriaceae. Supplementation with formula during breastfeeding transiently changed the composition of the gut microbiome, but the impact dissipated by six months of age. For example, Bifidobacterium longum, a bacterial species highly correlated with human milk consumption, was found to be significantly different only at 1 month of age but not at later time points. No immunologic differences were found to be associated with supplementation, including the development of T-cell subsets, B cells, or monocytes. These data suggest that early formula supplementation, given in addition to breast milk, has minimal lasting impact on the gut microbiome or immunity.     

An Observational Real-Life Study with a New Infant Formula in Infants with Functional Gastro-Intestinal Disorders

Functional gastro-intestinal disorders (FGIDs) impair the quality of life of many infants and their families. A formula with partial whey hydrolysate, starch, high magnesium content, prebiotic fructo-oligosaccharide and galacto-oligosaccharide and the probiotic Lactobacillus reuteri DSM 17938 was given during two weeks to 196 infants with at least two FGIDs. The efficacy was evaluated with the Cow Milk-associated Symptom Score (CoMiSS^®) and quality of life with the QUALIN score. The formula was shown to decrease FGIDs within three days (decrease of CoMiSS −1.29 (3.15) (mean (SD), p < 0.0001) followed by an improvement of quality of life after seven days (increase QUALIN +1.4 (7.8); p: 0.008). Constipation decreased from 18.8% to 6.5% within three days. In combination with reassurance and guidance, the nutritional intervention was shown to be effective in infants with FGIDS in real-life circumstances.     

The Resilience of the Health Care Safety Net, 1996–2001

Objective .  To determine how the capacity and viability of local health care safety nets changed over the last six years and to draw lessons from these changes.
Data Source .  The first three rounds (May 1996 to March 2001) of Community Tracking Study site visits to 12 communities.
Study Design .  Researchers visited the study communities every two years to interview leaders of local health care systems about changes in the organization, delivery, and financing of health care and the impact of these changes on people. For this analysis, we collected data on safety net capacity and viability through interviews with public and not-for-profit hospitals, community health centers, health departments, government officials, consumer advocates, academics, and others. We asked about the effects of market and policy changes on the safety net and how the safety net responded, as well as the impact of these changes on care for the low-income uninsured.
Principal Findings .  The safety net in three-quarters of the communities was stable or improved by the end of the study period, leading to improved access to primary and preventive care for the low-income uninsured. Policy responses to pressures such as the Balanced Budget Act and Medicaid managed care, along with effective safety net strategies and supportive conditions, helped reinforce the safety net. However, the safety net in three sites deteriorated and access to specialty services remained inadequate across the 12 sites.
Conclusions.  Despite pessimistic predictions and some notable exceptions, the health care safety net grew stronger over the past six years. Given considerable community variation, however, this analysis indicates that policymakers can apply a number of lessons from strong and improving safety nets to strengthen those that are weaker, particularly as the current economy poses new challenges.     

Readability and Content Characteristics of Powdered Infant Formula Instructions in the United States

Objectives This study aimed to assess readability characteristics and layout features, including reading grade level, text point size, dimensions (length and width), diagrams, key directions (warnings, proper hygiene, preparation and use, and storage), and compliance to International Code provisions of English-language instructions affixed to a representative sample of brand-name and generic powdered, infant formula containers currently available for purchase in the US. Methods During June 2014, comprehensive Internet searches were conducted to identify brand-name powdered infant formulas currently available for purchase in the US (n = 10). The English-language instruction section affixed to each formula container was evaluated for readability characteristics and layout features, including reading grade level, text point size, dimensions (length and width), diagrams, key directions (warnings, proper hygiene, preparation and use, and storage), and compliance to International Code. Results Overall, containers were similar in circumference (50.8 ± 7.3 cm) and height (14.0 ± 0.0 cm) and held an average of 656.0 ± 12.3 g (range 629–663 g) of powdered infant formula. Both Directions for Preparation and Use and Storage Instructions sections had average reading difficulty scores at the college level. Step-by-Step Preparation Directions and Warnings and Safe Handling sections had reading difficulty between the 8th and 9th grade level. All container labels contained three diagrams depicting step-by-step preparation instructions and a feeding chart. Overall, infant formula containers reviewed in our study adhered to compliance to International Code provisions. Conclusions As negative health outcomes are associated with inappropriately prepared infant formula feedings, healthcare providers should routinely query infant caregivers regarding their formula preparation and administration practices.     

Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti^®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti^®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.     

Infant mortality in Norway and Sweden 1975–88: a cause-specific analysis of an increasing difference

In a previous article, a high infant mortality was reported in the 1980s in Norway compared with Sweden. The aim of the present study was to assess secular trends in this difference, and to clarify whether the difference was confined to particular causes of death. Mortality rates, ratios of mortality rates and numbers of excess deaths were calculated on the basis of birth records comprising all livebirths in Norway and Sweden during the two periods 1975–79 and 1985–88. From the first to the second period, the infant mortality ratio for Norway to Sweden increased from 1.22 to 1.45 for single births, and from 1.23 to 1.54 for twin births. Increasing mortality ratios were observed for all ages at death. These were lowest in the early neonatal period (1.09 and 1.20 respectively) and highest in the postneonatal period (1.53 and 1.78 respectively). Within each cause of death category, the mortality rate in Norway was equal to or higher than the rate in Sweden. The highest mortality rate ratios were observed for sudden infant death syndrome (SIDS), 2.44 and 2.46 respectively, for the two time periods. SIDS was also the single cause of death that gave the largest contribution to the Norwegian excess mortality (45% and 53% overall, 65% and 78% for postneonatal deaths, and 65% and 79% for birthweights above 2500 g). In the second period, the excess SIDS mortality in Norway pertained mainly to infants of young mothers, infants of birth order two or more and twin births. An adverse trend for infants of young mothers in Norway was also observed in non-SIDS deaths. This suggests that in Norway, preventive health care should be improved, particularly for young mothers and their infants.