Avoidance of Inhaled Pollutants and Irritants in Asthma from a Salutogenic Perspective.

Much is known about the role of aeroallergens in asthma, but little is described about the damage caused by inhaled pollutants and irritants to the respiratory epithelium. In this context, the most frequent pollutants and irritants inhaled in the home environment were identified, describing the possible repercussions that may occur in the respiratory tract of the pediatric population with asthma and highlighting the role of the caregiver in environmental control through a salutogenic perspective. Searches were carried out in the MEDLINE/PubMed, Web of Science, Lilacs and Scopus databases for articles considered relevant for the theoretical foundation of this integrative review, in which interactions between exposure to pollutants and inhaled irritants and lung involvement. Articles published in the last 10 years that used the following descriptors were considered: air pollution; tobacco; particulate matter; disinfectants; hydrocarbons, fluorinated; odorants; chloramines; pesticide; asthma; and beyond Antonovsky's sense of coherence. Exposure to smoke and some substances found in cleaning products, such as benzalkonium chloride, ethylenediaminetetraacetic acid and monoethanolamine, offer potential risks for sensitization and exacerbation of asthma. The vast majority of the seven main inhaled products investigated provoke irritative inflammatory reactions and oxidative imbalance in the respiratory epithelium. In turn, the caregiver's role is essential in health promotion and the clinical control of paediatric asthma. From a salutogenic point of view, pollutants and irritants inhaled at home should be carefully investigated in the clinical history so that strategies to remove or reduce exposures can be used by caregivers of children and adolescents with asthma.

Marketing and child feeding.

OBJECTIVE: To carry out a narrative review on the use of marketing strategies in child nutrition, as well as potential implications for health professionals and children. DATA SOURCE: Searches were carried out on the PubMed, SciELO, and Google platforms, using the terms "child nutrition" or "industrialized baby food" or "infant formula" or "breast milk" or "breastfeeding" and "marketing", with original articles, review articles, institutional reports, institutional position documents and websites considered relevant to the topic being analyzed. DATA SYNTHESIS: Children's food marketing started with the industrialization of food and the resulting actions aimed at increasing sales and meeting commercial interests. Since its inception to the present, infant formulas have been the most widely used products, which has impacted breastfeeding practices. International and national institutions, that care for children's health, are searching for strategies to limit the abusive marketing of industrialized children's foods. Marketing strategies interfere with medical knowledge and actions, potentially influencing the guidance provided by pediatricians to families, and finally, compromising healthy eating practices at a critical period in life, with possible long-term effects. CONCLUSIONS: Health professionals, especially pediatricians, must provide the best care for children and families, and need to maintain the search for quality scientific information, not influenced by conflicts of interest. Updated and critical knowledge on the part of healthcare professionals can curb marketing strategies that aim to influence their actions.

Could children exposed to intimate partner violence against their mother have more functional gastrointestinal disorders?

OBJECTIVE: To analyze the association between child exposure to intimate partner violence (CEIPV) committed against their mother and functional gastrointestinal disorders (FGIDs) in school-age children. METHODS: A prospective cohort study was carried out that evaluated 626 mother-child pairs living in a poor urban area in the Northeast of Brazil. The mothers were asked about their children's exposure to intimate partner violence. Holden's classification was used, which investigates ten types of CEIPV from prenatal care. The number of exposures, age of onset, and the perpetrator of the exposure were also verified. The FGIDs in children were identified from the mother's responses to the questionnaire about pediatric gastrointestinal symptoms, Roma III version parent-report, translated and cross-culturally adapted into Brazilian Portuguese. RESULTS: FGIDs were more frequent among children exposed to violence than those not exposed (OR: 1.64; 95% CI: 1.04-2.58; p = 0.03). Likewise, in children who suffered four or more types of exposure (OR: 1.81; 95% CI: 1.10-2.96; p  = 0.01), in which the exposure started in the first two years of life (OR: 1.93; 95% CI: 1.08-3.47; p = 0.02) and in those whose biological father was the perpetrator of the violence (OR; 1.62; 95% CI: 1, 05-2.48; p = 0.02). CONCLUSION: Corroborating the proposal of the biopsychosocial model, CEIPV increases the chance of occurrence of FGIDs in school-age children. Therefore, early identification and proposals for appropriate interventions are suggested both for the prevention of CEIPV and for the prevention and follow-up of FGIDs.

Determining factors of child linear growth from the viewpoint of Bronfenbrenner's Bioecological Theory

Abstract Objective To analyze the factors associated with children's linear growth, according to the different subsystems of the 6Cs model and Bronfenbrenner's Bioecological Theory. Data sources Narrative review, carried out in the Scielo, Lilacs, Pubmed, and Science Direct databases, based on research using the terms Bioecological Theory, child growth, and risk factors, combined with the use of Boolean operators. Summary of findings According to the 6Cs model, proposed based on Bronfenbrenner's Bioecological Theory, the determining factors of children's linear growth are in six interrelated subsystems - cell, child, clan, community, country/state and culture. The empirical studies included in this review made it possible to analyze protection and risk factors within the subsystems. Among the protective factors: are adequate birth weight and satisfactory weight gain, breastfeeding for six months or more; proper hygienic habit of hand washing, proper elimination of feces, and access to clean water. As risk factors: low, birth weight and size, prematurity, multiple deliveries, short interval between deliveries, non-exclusive breastfeeding until the 3rd month, frequency and severity of infectious processes and anemia, little parental education, short maternal statur, inadequate maternal nutritional status, domestic violence, family poverty, food, and nutritional insecurity, living in rural areas or at high altitudes. Conclusion Children's linear growth is determined by interrelated factors that encompass aspects prior to the child's birth, as well as socioeconomic, political, family and community issues.

Determining factors of child linear growth from the viewpoint of Bronfenbrenner's Bioecological Theory.

OBJECTIVE: To analyze the factors associated with children's linear growth, according to the different subsystems of the 6Cs model and Bronfenbrenner's Bioecological Theory. DATA SOURCES: Narrative review, carried out in the Scielo, Lilacs, Pubmed, and Science Direct databases, based on research using the terms Bioecological Theory, child growth, and risk factors, combined with the use of Boolean operators. SUMMARY OF FINDINGS: According to the 6Cs model, proposed based on Bronfenbrenner's Bioecological Theory, the determining factors of children's linear growth are in six interrelated subsystems - cell, child, clan, community, country/state and culture. The empirical studies included in this review made it possible to analyze protection and risk factors within the subsystems. Among the protective factors: are adequate birth weight and satisfactory weight gain, breastfeeding for six months or more; proper hygienic habit of hand washing, proper elimination of feces, and access to clean water. As risk factors: low, birth weight and size, prematurity, multiple deliveries, short interval between deliveries, non-exclusive breastfeeding until the 3rd month, frequency and severity of infectious processes and anemia, little parental education, short maternal statur, inadequate maternal nutritional status, domestic violence, family poverty, food, and nutritional insecurity, living in rural areas or at high altitudes. CONCLUSION: Children's linear growth is determined by interrelated factors that encompass aspects prior to the child's birth, as well as socioeconomic, political, family and community issues.

Reference values for the cross-sectional area of the lumbar multifidus muscle in children.

BACKGROUND: The multifidus muscle plays a major role in the growth and postural control of children. Therefore, the reference values of the cross-sectional area (CSA) of the lumbar multifidus muscle represent an important tool for assessing muscle development and the early monitoring of musculoskeletal disorders. OBJECTIVE: The aim of this study was to provide percentile scores for the CSA of the lumbar multifidus muscle in eutrophic children aged 5 to 10 years. METHODS: This was a cross-sectional, observational study, involving 736 children. An anthropometric assessment was conducted and ultrasound (US) imaging was used to assess the CSA of the lumbar (vertebral level L5) multifidus muscle. The CSA was expressed as percentile scores. RESULTS: The CSA in the boys ranged from 1.8 cm2 to 5.3 cm2 and in girls from 1.9 cm2 to 5.9 cm. The CSA in the 50th percentile scores of both sexes was 3.4 cm2. There was an increase in the CSA between 5 and 7 years old in both sexes. The CSA presented a greater variance in girls than in boys. After 8 years of age, the multifidus CSA increased in girls and decreased in boys. CONCLUSION: The present study has provided percentile scores for the CSA of the lumbar multifidus muscle for eutrophic children aged 5 to 10 years. An increase was observed of the CSA of the multifidus muscle between the ages of 5 and 7 years and there were no differences in the CSA percentiles in relation to sex. An increase in the CSA after 8 years of age was only observed in the girls.

Vomiting and Gastric Motility in Early Brain Damaged Children With Congenital Zika Syndrome.

OBJECTIVES: This study investigated the occurrence of vomiting and gastric dysmotility in dysphagic children with congenital Zika syndrome (CZS) and assessed possible associations of these findings with the severity of dysphagia and the presence of tube feeding. METHODS: Forty-six children with CZS were assessed for dysphagia, and the occurrence of vomiting, dietary volume tolerance <15 mL/kg, and feeding time per meal >30 minutes were evaluated. Gastric antrum ultrasonography was used to detect the frequency of contractions and measure antral areas (at fasting and 15 minutes postprandial), from which the gastric emptying rate (GER) was calculated. Antral ultrasonography findings were compared with those of ten healthy controls. Vomiting and gastric motility were compared between CZS patients according to the severity of dysphagia and the requirement for tube feeding. RESULTS: Overall, 76% (35/46) of children with CZS had moderate-to-severe dysphagia (MSD), among whom 60% (21/35) were tube fed [MSD tube fed (MSDTF)]. Vomiting occurred in 54% (25/46) of children, whereas dietary volume intolerance and prolonged feeding time were observed in 59% (27/46) and 37% (17/46), respectively, most frequently in MSDTF patients. On ultrasound, 61% (28/46) of children with CZS had no antral contractions, whereas 90% (9/10) of controls did. Compared to healthy controls, GER was eight-fold lower in children with CZS and 60-fold lower in MSDTF children. CONCLUSIONS: In dysphagic children with CZS, vomiting, volume intolerance, and prolonged feeding time were frequent and possibly associated with impaired antral contraction and delayed gastric emptying, especially in cases of severe dysphagia and tube feeding.

Psychological stress in asthma: repercussions on epigenetics-genetics, immune responses, and pulmonary function in the pediatric population.

In the assessment of childhood asthma, identifying the risk factors associated with exacerbations and broadening this view to understand psychological stress and its repercussions on the inflammatory process of asthma allow a different perspective on this biopsychosocial disease. Psychological stress, as a risk factor for the onset and noncontrol of asthma, has been increasingly evaluated from the perspective of the repercussions on the body of the stimulus generated in the hypothalamic-pituitary axis and adrenal glands, with cortisol release and immune system action. These processes trigger changes in T helper 2 cells, which polarize allergic processes, and dysfunctions in immune tolerance mechanisms, with a decrease in regulatory T cells. Genetic and epigenetic changes in ß2-adrenergic and glucocorticoid receptors, with decreased response to these drugs, were also identified in studies, in addition to changes in respiratory function patterns, with worsening of obstruction and inflammation identified via decreased forced expiratory volume in one second and increased exhaled inflammatory gases in allergic asthma. Therefore, the present review sought to identify studies on the effect of personal and parental acute or chronic psychological stress, emphasizing the repercussions on genetics, epigenetics, and immune and pulmonary functional and inflammatory responses in the pediatric population.

Acute diarrhea with blood: diagnosis and drug treatment.

OBJECTIVE: To restate the epidemiological importance of Shigella in acute diarrhea with blood, providing an overview of the treatment and stressing the need for the correct indication of antibiotic therapy. SOURCES OF DATA: A search was carried out in the Medline and Scopus databases, in addition to the World Health Organization scientific documents and guidelines, identifying review articles and original articles considered relevant to substantiate the narrative review. SYNTHESIS OF DATA: Different pathogens have been associated with acute diarrhea with blood; Shigella was the most frequently identified. The manifestations of shigellosis in healthy individuals are usually of moderate intensity and disappear within a few days. There may be progression to overt dysentery with blood and mucus, lower abdominal pain, and tenesmus. Conventional bacterial stool culture is the gold standard for the etiological diagnosis; however, new molecular tests have been developed to allow the physician to initiate targeted antibacterial treatment, addressing a major current concern caused by the increasing resistance of Shigella. Prevention strategies include breastfeeding, hygiene measures, health education, water treatment, and the potential use of vaccines. CONCLUSIONS: Acute diarrhea is an important cause of mortality in children under 5 years and shigellosis is the leading cause of acute diarrhea with blood worldwide. The current concern is the increase in microbial resistance to the recommended antibiotics, which brings an additional difficulty to therapeutic management. Although no vaccine is yet available against Shigella, several candidates are undergoing clinical trials, and this may be the most cost-effective preventative measure in future.

STRONGkids: Predictive Validation in Brazilian Children.

OBJECTIVES: The aim of the study is to assess STRONGkids as a tool for predicting weight loss and length of hospital stay in children and to determine whether the anthropometric diagnosis of nutritional status at the time of admission was associated with weight loss and length of hospital stay. METHODS: A methodological study recruiting 245 children age between 1 and 10 years of age admitted to a tertiary hospital. The participants were weighed daily until discharge. Validation of the STRONGkids tool for the identification of patients sustaining weight loss at the end of hospitalization involved the calculation of sensitivity, specificity, and positive and negative predictive values, and anthropometric assessment. RESULTS: A total of 129 (52.7%) children lost weight at the end of hospitalization. Of these, 73 (56.6%) lost over 2% of their weight on admission. The tool had a sensitivity of 55.8%, a specificity of 38.8% and a positive predictive value of 50.3% in identifying children who lost weight. The anthropometric assessment had a sensitivity of 26.5%, a specificity of 75.9%, and a positive predictive value of 49.1%. CONCLUSIONS: The model used to develop the STRONGkids tool incorporated clinical evaluation to a greater extent than the assessment of nutritional status. The tool, however, had a low sensitivity and a high percentage of false positives. Therefore, it should be considered as a preliminary evaluation tool and its use should be complemented with clinical data.

The balance between the serum levels of IL-6 and IL-10 cytokines discriminates mild and severe acute pneumonia.

BACKGROUND: To identify markers for earlier diagnosis of severe pneumonia, we assess the correlation between serum cytokine profile of children with different pneumonia severity. METHODS: In 25 hospitalized children, 7 with mild pneumonia and 18 with severe pneumonia, the serum concentration of 11 cytokines in three sampling times were dosed. Statistical analysis included parametric and non-parametric tests, Pearson correlation and ROC curve for cut-off definition of cytokines. RESULTS: At admission, IL-6 serum levels were high in mild or severe pneumonia, and was associated to vomiting (P = 0.019) in both groups; and also to dyspnea (P = 0.012) and white blood cell count (P = 0.045) in patients with severe pneumonia. IL-10 levels were also high in patients with pneumonia and were associated to lymphocytosis (P = 0.025). The ROC curve of the IL-6:IL-10 serum levels ratio discriminated severe pneumonia cases at admission, and persistence of infection in the third day of antibiotic therapy, with positive predictive values of 93% and 89%, respectively. CONCLUSIONS: The balance between IL-6 and IL-10 serum levels showed to be a more discriminative marker for severity definition and evaluation of recovery in patients with pneumonia.

Fecal Microbiota and Diet of Children with Chronic Constipation.

Many factors explain dysbiosis in chronic constipation (CC), such as a low-fiber diet. The objective of this study was to compare the fecal microbiota of constipated and nonconstipated children and their intake frequencies of food. Methods. This observational study included 79 children (M/F 43/36) aged six to 36 months divided into two groups: cases (39 constipated children) and controls (40 nonconstipated children). We used a structured form to collect demographic variables, conducted anthropometric assessment, and collected food intake frequency data. The fecal microbiota of the stool samples was analyzed by real-time polymerase chain reaction (PCR) using the fluorophore SYBR® Green. Results. Constipated children had a smaller concentration of Lactobacillus per milligram of stool (p = 0.015) than nonconstipated children, but the concentration of Bifidobacterium per milligram of stool (p = 0.323) and the intake of fruits, vegetables (p = 0.563), and junk food (p = 0.093) of the two groups did not differ. Constipated children consumed more dairy products (0.45 ± 0.8; p > 0.001), were more frequently delivered via caesarean section (69.2%), were weaned earlier (median: 120; 60Q1-240Q3), and had a family history of constipation (71.8%). Conclusions. Children with CC have a smaller concentration of Lactobacillus in their stools and consume more dairy products.

[Socioeconomic, cultural and demographic maternal factors associated with dietary patterns of infants]. / Fatores socioeconômicos, culturais e demográficos maternos associados ao padrão alimentar de lactentes.

OBJECTIVE: To analyze dietary patterns of infants and its association with maternal socioeconomic, cultural, and demographic variables. METHODS: A cross-sectional study was conducted with two groups of mothers of children up to 24 months (n=202) living in the city of Maceió, Alagoas, Northeast Brazil. The case group consisted of mothers enrolled in a Family Health Unit. The comparison group consisted of mothers who took their children to two private pediatric offices of the city. Dietary intake was assessed using a qualitative and validated food frequency questionnaire (FFQ). The evaluation of the FFQ was performed by a method in which the overall rate of consumption frequency is converted into a score. RESULTS: Children of higher income families and mothers with better education level (control group) showed the highest median of consumption scores for fruits and vegetables (p<0.01) and meat, offal, and eggs (p<0.01), when compared with children of the case group. On the other hand, the median of consumption scores of manufactured goods was higher among children in the case group (p<0.01). CONCLUSIONS: Maternal socioeconomic status influenced the quality of food offered to the infant. In the case group, children up to 24 months already consumed industrial products instead of healthy foods on their menu.

Validation of psychosocial scales for physical activity in university students.

OBJECTIVE Translate the Patient-centered Assessment and Counseling for Exercise questionnaire, adapt it cross-culturally and identify the psychometric properties of the psychosocial scales for physical activity in young university students. METHODS The Patient-centered Assessment and Counseling for Exercise questionnaire is made up of 39 items divided into constructs based on the social cognitive theory and the transtheoretical model. The analyzed constructs were, as follows: behavior change strategy (15 items), decision-making process (10), self-efficacy (6), support from family (4), and support from friends (4). The validation procedures were conceptual, semantic, operational, and functional equivalences, in addition to the equivalence of the items and of measurements. The conceptual, of items and semantic equivalences were performed by a specialized committee. During measurement equivalence, the instrument was applied to 717 university students. Exploratory factor analysis was used to verify the loading of each item, explained variance and internal consistency of the constructs. Reproducibility was measured by means of intraclass correlation coefficient. RESULTS The two translations were equivalent and back-translation was similar to the original version, with few adaptations. The layout, presentation order of the constructs and items from the original version were kept in the same form as the original instrument. The sample size was adequate and was evaluated by the Kaiser-Meyer-Olkin test, with values between 0.72 and 0.91. The correlation matrix of the items presented r < 0.8 (p < 0.05). The factor loadings of the items from all the constructs were satisfactory (> 0.40), varying between 0.43 and 0.80, which explained between 45.4% and 59.0% of the variance. Internal consistency was satisfactory (α ≥ 0.70), with support from friends being 0.70 and 0.92 for self-efficacy. Most items (74.3%) presented values above 0.70 for the reproducibility test. CONCLUSIONS The validation process steps were considered satisfactory and adequate for applying to the population.

[Low birth weight and obesity: causal or casual association?]. / Baixo peso ao nascer e obesidade: associação causal ou casual?

OBJECTIVE: To present the conceptual foundations that explain how events occurring during intrauterine life may influence body development, emphasizing the interrelation between low birth weight and risk of obesity throughout life. DATA SOURCES: Google Scholar, Library Scientific Electronic Online (SciELO), EBSCO, Scopus, and PubMed were the databases. "Catch-up growth", "life course health", "disease", "child", "development", "early life", "perinatal programming", "epigenetics", "breastfeeding", "small baby syndrome", "phenotype", "micronutrients", "maternal nutrition", "obesity", and "adolescence" were isolated or associated keywords for locating reviews and epidemiological, intervention and experimental studies published between 1934 and 2014, with complete texts in Portuguese and English. Duplicate articles, editorials and reviews were excluded, as well as approaches of diseases different from obesity. DATA SYNTHESIS: Within 47 selected articles among 538 eligible ones, the thrifty phenotype hypothesis, the epigenetic mechanisms and the development plasticity were identified as fundamental factors to explain the mechanisms involved in health and disease throughout life. They admit the possibility that both cardiometabolic events and obesity originate from intrauterine nutritional deficiency, which, associated with a food supply that is excessive to the metabolic needs of the organism in early life stages, causes endocrine changes. However, there may be phenotypic reprogramming for low birth weight newborns from adequate nutritional supply, thus overcoming a restrictive intrauterine environment. Therefore, catch-up growth may indicate recovery from intrauterine constraint, which is associated with short-term benefits or harms in adulthood. CONCLUSIONS: Depending on the nutritional adequacy in the first years of life, developmental plasticity may lead to phenotype reprogramming and reduce the risk of obesity.

Influence of preeclampsia and gestational obesity in maternal and newborn levels of vitamin D.

BACKGROUND: In recent years, a high prevalence of vitamin D deficiency amongst pregnant women and newborns has been observed throughout several regions of the world, especially in the presence of preeclampsia (PE) or obesity (OB). The aim of this study was to investigate whether nonobese and obese preeclamptic pregnant women and their newborns have low 25(OH)D compared with nonobese and obese nonpreeclamptic pregnant women; and to verify whether the maternal level of this vitamin correlates with the newborns' level. METHODS: This is a cross-sectional study conducted with 179 pregnant women recruited immediately before delivery, divided into four groups: PE(+)/OB(-); PE(+)/OB(+); PE(-)/OB(+); and PE(-)/OB(-), with gestational age ≥ 34 weeks. Maternal peripheral blood and newborns umbilical cord blood were collected and 25(OH)D levels were measured by chemiluminescence (LIAISON®). RESULTS: Infants born to preeclamptic mothers had a lower median 25(OH)D level than those born to nonpreeclamptic mothers (p < 0.01). Obese pregnant women and their newborns had higher frequencies of 25(OH)D deficiency, but the difference with respect to nonobese pregnant women and their newborns was not significant. The vitamin D status of preeclamptic obese women was not worse than that of their nonobese counterparts. Newborns and maternal 25(OH)D levels were significantly correlated (p = 0.01). Obesity weakened this correlation. CONCLUSIONS: Preeclamptic women and their newborns presented higher frequencies of 25(OH)D deficiency, but 25(OH)D levels were not significantly influenced by obesity. Obese pregnant women transferred less 25(OH)D to their fetuses.

Allergy to cow's milk proteins: what contribution does hypersensitivity in skin tests have to this diagnosis?

Food allergy is an immunologically mediated adverse reaction to food protein. Cow's milk protein allergy (CMPA) is the most frequent type and is the one that is most difficult to diagnose. This study had the objective of analyzing the accuracy of hypersensitivity and specific IgE skin tests among children with CMPA and predominantly gastrointestinal clinical manifestations. The participants in this study were 192 children aged one and five (median of 2 yr). Among these, 122 underwent open oral challenge to the suspected food. After evaluating the sensitivity, specificity and positive and negative predictive values (respectively, PPV and NPV) of skin and specific IgE tests in relation to the gold standard (open oral challenge); all the children underwent the skin prick test (SPT), specific IgE test and atopy patch test (APT) for cow's milk, eggs, wheat and peanuts and the open oral challenge for the food to which the child was sensitive or had suspected sensitivity. Presence of food allergy was confirmed for 50 children (40.9%). Among these cases, 44/50 (88%) were of allergy to cow's milk protein. Children who presented a positive response to an oral challenge to cow's milk protein were considered to be cases, while the controls were children with negative response. Twenty-two of the 44 cases (50.0%) presented symptoms within the first 4 h after the challenge. The SPT presented 31.8% sensitivity, 90.3% specificity, 66.7% PPV and 68.4% NPV. The APT presented 25.0% sensitivity, 81.9% specificity, 45.8% PPV and 64.1% NPV. The specific IgE test presented, respectively, 20.5%, 88.9%, 52.9% and 64.6%. Despite the operational difficulty and the possible exposure risk, oral challenge is the best method for diagnosing CMPA, because of the low sensitivity and PPV of skin and specific IgE tests.

Efficacy of Bifidobacterium breve and Lactobacillus casei oral supplementation on necrotizing enterocolitis in very-low-birth-weight preterm infants: a double-blind, randomized, controlled trial.

BACKGROUND: Probiotics are used for the prevention of necrotizing enterocolitis (NEC) because of their positive effects on intestinal motor function, modulation of inflammatory response, and mucosal barrier function. OBJECTIVE: The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage ≥ 2 by the criteria of Bell in very-low-birth-weight preterm infants. DESIGN: A double-blind, randomized, controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth. The intervention group was composed of 119 infants who received human milk with probiotic supplementation (B. breve and L. casei) and a control group of 112 infants who received human milk containing no probiotics. The primary outcome was the occurrence of NEC stage ≥ 2 as defined by Bell's modified criteria. RESULTS: Four confirmed cases of NEC stage ≥ 2 by Bell's criteria occurred only in the control group. CONCLUSIONS: Oral supplementation of B. breve and L. casei reduced the occurrence of NEC (Bell's stage ≥ 2). It was considered that an improvement in intestinal motility might have contributed to this result. This trial was registered at www.isrctin.org as number 67165178 (International Standard Randomized Controlled Trial).