ABSTRACT
Avoidant/restrictive food intake disorder (ARFID) has recently been added to the DSM V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) as a new class of eating disorders (EDs). ARFID is characterized by a lack of interest in eating or avoiding specific types of foods because of their sensory characteristics. This avoidance results in decreased nutritional intake, eventually causing nutritional deficiencies. In severe cases, ARFID can lead to dependence on oral nutritional supplements, which interferes with psychosocial functioning. The prevalence of ARFID can be as high as 3% in the general population, and it is often associated with gastrointestinal symptoms and mainly appears in children with anxiety disorders. Given the high prevalence of ARFID, a rapid and systematic nutrition survey should be conducted during every pediatric consultation. Its treatment should also be adapted depending on the severity of the nutritional problem and may involve hospitalization with multidisciplinary care (pediatrician, nutritional therapist, dietitian, psychologists, and speech therapists).
Subject(s)
Avoidant Restrictive Food Intake Disorder , Malnutrition/etiology , Anxiety/complications , Anxiety/physiopathology , Anxiety/psychology , Anxiety/therapy , Child , Humans , Malnutrition/diagnosis , Malnutrition/psychology , Malnutrition/therapy , Pediatrics , Risk FactorsABSTRACT
Foods for special medical purposes (FSMPs) with a protein fraction made of hydrolyzed rice protein (HRPs) have been on the market in Europe since the 2000s for the treatment of cow's milk protein allergy (CMPA). HRP formulas (HRPFs) are proposed as a plant-based alternative to cow's milk protein-based extensively hydrolyzed formulas (CMP-eHF) beside the soy protein formulas whose use in CMPA is controversial. HRPFs do not contain phytoestrogens and are derived from non-genetically modified rice. HRPFs are strictly plant-based apart from the addition of vitamin D3 (cholecalciferol). As the amino acid content of rice proteins differs from that of human milk proteins, the protein quality of these formulas is improved by supplementation with free lysine, threonine, and tryptophan. The consumption of HRPFs has risen: for example, in France HRPFs account for 4.9% in volume of all formulas for children aged 0-3 years. Several studies have shown the adequacy of HRPFs in treating CMPA. They ensure satisfactory growth from the 1st weeks of life for infants and toddlers, both in healthy children and in those with CMPA. HRPFs can be used to treat children with CMPA either straightaway or in second intention in cases of poor tolerance to CMP-eHF for organoleptic reasons or for lack of efficacy. In France, the cost of HRPFs is close to that of regular infant or follow-on formulas.
Subject(s)
Infant Formula , Milk Hypersensitivity/diet therapy , Oryza , Plant Proteins, Dietary/administration & dosage , Protein Hydrolysates/administration & dosage , Dietary Carbohydrates/administration & dosage , Dietary Carbohydrates/analysis , Humans , Infant , Infant Formula/chemistry , Lipids/administration & dosage , Lipids/analysis , Milk Proteins/adverse effects , Plant Proteins, Dietary/analysis , Protein Hydrolysates/analysisABSTRACT
Due to transient gut immaturity, most very preterm infants receive parenteral nutrition (PN) in the first few weeks of life. Yet providing enough protein and energy to sustain optimal growth in such infants remains a challenge. Extrauterine growth restriction is frequently observed in very preterm infants at the time of discharge from hospital, and has been found to be associated with later impaired neurodevelopment. A few recent randomized trials suggest that intensified PN can improve early growth; whether or not such early PN improves long-term neurological outcome is still unclear. Several other questions regarding what is optimal PN for very preterm infants remain unanswered. Amino acid mixtures designed for infants contain large amounts of branched-chain amino acids and taurine, but there is no consensus on the need for some nonessential amino acids such as glutamine, arginine, and cysteine. Whether excess growth in the first few weeks of life, at a time when very preterm infants receive PN, has an imprinting effect, increasing the risk of metabolic or vascular disease at adulthood continues to be debated. Even though uncertainty remains regarding the long-term effect of early PN, it appears reasonable to propose intensified initial PN. The aim of the current position paper is to review the evidence supporting such a strategy with regards to the early phase of nutrition, which is mainly covered by parenteral nutrition. More randomized trials are, however, needed to further support this type of approach and to demonstrate that this strategy improves short- and long-term outcome.
Subject(s)
Infant, Premature , Parenteral Nutrition/methods , Amino Acids/administration & dosage , Body Composition , Child Development , Electrolytes/administration & dosage , Glucose/administration & dosage , Growth Disorders/prevention & control , Humans , Infant, Newborn , Lipids/administration & dosage , Nutritional Status , Water/administration & dosageSubject(s)
Hyperlipoproteinemia Type II/diagnosis , Lipids/blood , Mass Screening/methods , Child , HumansABSTRACT
Cow's milk is one of the most common foods responsible for allergic reactions in children. Cow's milk allergy (CMA) involves immunoglobulin E (IgE)- and non-IgE-mediated reactions, the latter being both variable and nonspecific. Guidelines thus emphasize the need for physicians to recognize the specific syndromes of CMA and to respect strict diagnostic modalities. Whatever the clinical pattern of CMA, the mainstay of treatment is the elimination from the diet of cow's milk proteins. The challenge is that both the disease and the elimination diet may result in insufficient height and weight gain and bone mineralization. If, during CMA, the mother is not able or willing to breastfeed, the child must be fed a formula adapted to CMA dietary management, during infancy and later, if the disease persists. This type of formula must be adequate in terms of allergic efficacy and nutritional safety. In older children, when CMA persists, the use of cow's milk baked or heated at a sufficient temperature, frequently tolerated by children with CMA, may help alleviate the stringency of the elimination diet. Guidance on the implementation of the elimination diet by qualified healthcare professionals is always necessary. This guidance should also include advice to ensure adequate bone growth, especially relating to calcium intake. Specific attention should be given to children presenting with several risk factors for weak bone mineral density, i.e., multiple food allergies, vitamin D deficiency, poor sun exposure, steroid use, or severe eczema. When CMA is outgrown, a prolonged elimination diet may negatively impact the quality of the diet over the long term.
Subject(s)
Milk Hypersensitivity/therapy , Animals , Bone Diseases, Metabolic/prevention & control , Breast Feeding , Cooking , Dietary Services , Growth Disorders/etiology , Growth Disorders/prevention & control , Humans , Infant , Infant Formula , Milk Hypersensitivity/immunology , Practice Guidelines as Topic , Risk FactorsABSTRACT
Vitamin A (retinol) fulfills multiple functions in vision, cell growth and differentiation, embryogenesis, the maintenance of epithelial barriers and immunity. A large number of enzymes, binding proteins and receptors facilitate its intestinal absorption, hepatic storage, secretion, and distribution to target cells. In addition to the preformed retinol of animal origin, some fruits and vegetables are rich in carotenoids with provitamin A precursors such as ß-carotene: 6µg of ß-carotene corresponds to 1µg retinol equivalent (RE). Carotenoids never cause hypervitaminosis A. Determination of liver retinol concentration, the most reliable marker of vitamin A status, cannot be used in practice. Despite its lack of sensitivity and specificity, the concentration of retinol in blood is used to assess vitamin A status. A blood vitamin A concentration below 0.70µmol/L (200µg/L) indicates insufficient intake. Levels above 1.05µmol/L (300µg/L) indicate an adequate vitamin A status. The recommended dietary intake increases from 250µg RE/day between 7 and 36 months of age to 750µg RE/day between 15 and 17 years of age, which is usually adequate in industrialized countries. However, intakes often exceed the recommended intake, or even the upper limit (600µg/day), in some non-breastfed infants. The new European regulation on infant and follow-on formulas (2015) will likely limit this excessive intake. In some developing countries, vitamin A deficiency is one of the main causes of blindness and remains a major public health problem. The impact of vitamin A deficiency on mortality was not confirmed by the most recent studies. Periodic supplementation with high doses of vitamin A is currently questioned and food diversification, fortification or low-dose regular supplementation seem preferable.
Subject(s)
Vitamin A Deficiency/diagnosis , Vitamin A/blood , Adolescent , Breast Feeding , Child , Child, Preschool , Dose-Response Relationship, Drug , Europe , Female , Guideline Adherence , Humans , Infant , Liver/metabolism , Male , Nutritional Requirements , Reference Values , Vitamin A/administration & dosage , Vitamin A Deficiency/blood , Vitamin A Deficiency/therapySubject(s)
Chronic Disease/epidemiology , Chronic Disease/prevention & control , Life Style , Adult , Body Mass Index , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/prevention & control , Epigenomics , France/epidemiology , Humans , Neoplasms/epidemiology , Neoplasms/prevention & control , Obesity/epidemiology , Obesity/prevention & control , Risk FactorsSubject(s)
Breast Feeding , Infant Formula , Breast Feeding/statistics & numerical data , France , Humans , Infant, Newborn , Nutritive ValueABSTRACT
In the different types of children's hypercholesterolemia, some severe inherited monogenic forms, transmitted as a dominant trait, carry a high risk of early cardiovascular events in young adults and a decrease in life expectancy, warranting the initiation of a preventive cholesterol-lowering treatment early in childhood. As in adult patients, statins are the first-line drugs. The purpose of this article is to review the existing recommendations for their indications in children, their benefits, their tolerance, as well as their prescription and monitoring modalities.
Subject(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Hypercholesterolemia/drug therapy , Child , Humans , Practice Guidelines as TopicSubject(s)
Breast Feeding , Infant Food , Infant Nutritional Physiological Phenomena , Age Factors , Celiac Disease/etiology , Celiac Disease/prevention & control , Food Hypersensitivity/etiology , Food Hypersensitivity/prevention & control , Glutens/administration & dosage , Glutens/adverse effects , Humans , Infant , Risk FactorsABSTRACT
Very early in life, sodium intake correlates with blood pressure level. This warrants limiting the consumption of sodium by children. However, evidence regarding exact sodium requirements in that age range is lacking. This article focuses on the desirable sodium intake according to age as suggested by various groups of experts, on the levels of sodium intake recorded in consumption surveys, and on the public health strategies implemented to reduce salt consumption in the pediatric population. Practical recommendations are given by the Committee on nutrition of the French Society of Pediatrics in order to limit salt intake in children.
Subject(s)
Hypertension/etiology , Hypertension/prevention & control , Nutritional Requirements , Sodium Chloride, Dietary/administration & dosage , Sodium Chloride, Dietary/adverse effects , Adolescent , Adult , Age Factors , Child , Child, Preschool , Dose-Response Relationship, Drug , Female , France , Humans , Infant , Infant, Newborn , Male , Nutrition Surveys , Reference Values , Statistics as TopicABSTRACT
Over the past few years, we have observed increasing consumption of inappropriate plant milks as an alternative to infant milk formula. Some families believe that foods labeled as natural are the most healthy and an appropriate nutritional choice. However, their composition does not respect European recommendations. They are always hypocaloric and protein, vitamin, and mineral concentrations are inadequate. The aim of this study was to report severe nutritional complications after inappropriate plant milk consumption. Between 2008 and 2011, we studied severe nutritional deficiencies caused by consumption of plant milks bought in health food stores or online shops. Infants were identified in our centers and examined through medical history, physical examination, and laboratory testing. Nine cases of infants aged from 4 to 14 months were observed. In all cases, these milks were used as an alternative to milk formulas for supposed cow's milk allergy. At diagnosis, four patients were aged 6 months or less. They had received plant milk exclusively for 1-3 months. The beverages consumed were rice, soya, almond and sweet chestnut milks. In three cases, infants presented severe protein-calorie malnutrition with substantial hypoalbuminemia (<20 g/L) and diffuse edema. In the other cases, the nutritional disorders were revealed by a refractory status epilepticus related to severe hypocalcemia (one case), growth arrest of both height and weight secondary to insufficient caloric intake (five cases), and severe cutaneous involvement (one case). Five children had severe iron deficiency anemia (<70 g/L), three children had a very low 25-hydroxy vitamin D level (nutritional rickets), and two had severe hyponatremia (<130 mmoL/L). Milk alternative beverages expose infants to severe nutritional deficiencies. Serious complications can occur. Early, exclusive, and extended use is riskier. These diseases are preventable, and parental education should be provided. Statutory measures forbidding their use in young infants should be organized to slow down the progress of this social trend.
Subject(s)
Avitaminosis/etiology , Diet, Vegetarian/adverse effects , Food, Organic/adverse effects , Infant Formula/chemistry , Infant Nutrition Disorders/etiology , Protein Hydrolysates/adverse effects , Protein Hydrolysates/chemistry , Protein-Energy Malnutrition/etiology , Soy Milk/chemistry , Trace Elements/deficiency , Avitaminosis/blood , Female , France , Humans , Infant , Infant Nutrition Disorders/blood , Infant, Newborn , Male , Nutrition Surveys , Nutritional Requirements , Nutritive Value , Protein-Energy Malnutrition/blood , Retrospective Studies , Risk Factors , Trace Elements/bloodABSTRACT
Lipids are an important source of energy for young children and play a major role in the development and functioning of nervous tissue. Essential fatty acids and their long-chain derivatives also fulfill multiple metabolic functions and play a role in the regulation of numerous genes. The Food and Agriculture Organization of the United Nations (FAO), the World Health Organization (WHO), and the French Agency for Food, Environmental and Occupational Health & Safety (Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail [ANSES]) have recently recommended a minimum daily intake in preformed long-chain polyunsaturated fatty acids (LC-PUFAs): arachidonic acid (ARA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Mother's milk remains the only reference, but the large variability in its DHA content does not guarantee that breastfed children receive an optimal DHA intake if the mother's intake is insufficient. For children fed with infant formulas, ARA and DHA intake is often below the recommended intake because only one-third of infant formulas available on the market in France are enriched in LC-PUFAs. For all children, linoleic acid (LA) intake is on average higher than the minimal recommended values. The consequences of these differences between intake and recommended values are uncertain. A cautious attitude is to come close to the current recommendations and to advise sufficient consumption of DHA in breastfeeding women. For bottle-fed children, infant formulas enriched in LC-PUFAs and with moderate levels of LA should be preferred. LC-PUFA-rich fish should be consumed during breastfeeding, and adapted vegetable oils when complementary foods are introduced.
Subject(s)
Energy Intake , Lipids , Pediatrics , Recommended Dietary Allowances , Arachidonic Acid/administration & dosage , Child Nutritional Physiological Phenomena , Child, Preschool , Docosahexaenoic Acids/administration & dosage , Eicosapentaenoic Acid/administration & dosage , Fatty Acids, Unsaturated/administration & dosage , France , Humans , Lipids/administration & dosage , Nutritional Status , Societies, Medical , World Health OrganizationABSTRACT
UNLABELLED: Acute gastroenteritis (AGE) is a very common reason for pediatric consultations. Various expert committees have issued guidelines for its management, based on systematic use of an oral rehydration solution (ORS), early appropriate nutrition (most recent previous diet), and avoiding routine treatment with medication. The aim of the study was to assess the application of these guidelines by pediatricians in outpatient practice for mild to moderate AGE. A secondary objective was to question pediatricians about their practices for vaccination against rotavirus. METHODS: In June 2012, e-mail requests were sent to 1187 pediatricians in private practice, asking them to complete an anonymous questionnaire online at the website of the French Association of Pediatricians in Outpatient Practice. RESULTS: A total of 641 (54%) responses could be analyzed. Nearly all the pediatricians recommended early resumption of nutrition after administration of ORS. Depending on the child's age, 16 to 23% reported they would recommend resuming feeding with lactose-free milk, and 80% would advise an antidiarrhea diet for children older than 6 months. The drugs prescribed most often were, in decreasing order, racecadotril (acetorphan), diosmectite, and probiotics. Although 90% of the pediatricians prescribed vaccination against rotavirus, 65% estimated that it was performed in more than half of all children. CONCLUSION: This study of the management of moderate acute gastroenteritis shows variable adhesion to guidelines by pediatricians treating outpatients. Although ORS, maintenance of breastfeeding, and early nutrition after ORS are now widely applied, the type of nutrition recommended often failed to meet guidelines. Drug prescription is still too frequent. Anti-rotavirus vaccine is prescribed often but is administered much less frequently.
Subject(s)
Gastroenteritis/therapy , Pediatrics , Practice Patterns, Physicians'/statistics & numerical data , Acute Disease , Antidiarrheals/therapeutic use , Diet , Female , France , Humans , Male , Middle Aged , Private Practice , Probiotics/therapeutic use , Rehydration Solutions/administration & dosage , Rotavirus Vaccines/administration & dosage , Surveys and QuestionnairesABSTRACT
Processed baby foods designed for infants (4-12 months) and toddlers (12-36 months) (excluding infant formula, follow-on formula, the so-called growing-up milks, and cereal-based foods for infants), which are referred to as baby foods, are specific products defined by a European regulation (Directive 2006/125/CE). According to this Directive, such foods have a composition adapted to the nutritional needs of children of this age and should comply with specifications related to food safety in terms of ingredients, production processes, and prevention of infectious and toxicological hazards. Hence, they differ from ordinary foods and from non-specific processed foods. This market segment includes the full range of foods that can be part of children's diet: dairy products (dairy desserts, yoghurts, and fresh cheese), sweet products (nondairy desserts, fruit, and drinks), and salty products (soups, vegetable-based foods, meat, fish, and full dishes). This market amounted to 89,666 MT in France in 2011 and 83,055 MT in 2010 (a total of 325,524 MT in the 27 countries of the European Union in 2010, including 90,438 MT in Germany, 49,144 MT in Spain, and 40,438 MT in Italy). The consumption of baby foods in France varies with infant age and parental choice. Baby foods account for 7 % of total energy intake at 4-5 months, 28 % at 6-7 months, 27 % at 8-11 months, 17 % at 1-17 months, and 11 % at 18-24 months. Among parents, 24 % never offer their children any baby foods, 13 % do so 1-3 days/week and 63 % 4-7 days/week. Among consumers, 55 % of children eat more than 250 g/day of baby foods. As baby foods only account for a minor fraction of overall food intake, their impact on the quality of young children's diet is much less than that of growing-up milks, particularly for preventing insufficient iron and vitamin D intake. Their consumption, however, has an indirect benefit on the nutritional quality of the diet and on food safety, particularly regarding toxicological hazards, as it postpones the introduction of non-specific processed foods, which are inadequate for this age group owing to both their nutritional composition and lower food safety control. Baby foods represent a family of products meeting parents' expectations and adapted to infants and young children. They are clearly beneficial in terms of food safety, but the nutritional benefit to be expected from their consumption is minimal: their main advantage is postponing or decreasing the consumption of non-specific industrially processed foods.
Subject(s)
Edible Grain/standards , Infant Food/standards , Infant Formula/standards , Infant Nutrition Disorders/prevention & control , Nutritional Requirements , Child, Preschool , Female , Food Safety , France , Humans , Infant , Infant Nutrition Disorders/etiology , Male , Nutritive Value , Pediatrics , Societies, MedicalABSTRACT
UNLABELLED: The objective of this study was to assess the efficacy in terms of growth and tolerance of an infant formula based on hydrolyzed rice proteins. PATIENTS AND METHODS: Healthy infants, born at term, less than 1 month old, and exclusively fed an infant formula based on hydrolyzed rice proteins until their diet was diversified, were included in this open-label, multicenter study. The main outcome measure was daily weight gain during the study period. The infant's weight, height, body mass index (BMI), and the data concerning tolerance (digestive disorders, allergy manifestations) were collected at inclusion in the study, at 2 and 4 months, and before diversifying the infant's diet between 4 and 6 months. The growth parameters were compared to the WHO standards by calculating the Z-score. RESULTS: Seventy-eight infants were included. The mean daily weight gain over 5 months was 23.2 ± 4.3 g/day, identical to the WHO standards (22.2 ± 1.8 g/day, P = 0.09). During the study period, the Z-scores for weight, height, and BMI varied between +1.1 and -0.5 SD according to the WHO standards. Formula acceptance and tolerance were both good. CONCLUSION: The infant formula studied, based on hydrolyzed rice proteins, was well tolerated and led to normal growth over the first few months of life, comparable to the WHO standards.
Subject(s)
Dietary Proteins , Growth , Infant Formula , Female , Humans , Hydrolysis , Infant Nutritional Physiological Phenomena , Infant, Newborn , Male , OryzaABSTRACT
The prevalence of breastfeeding in France is one of the lowest in Europe: 65% of infants born in France in 2010 were breastfed when leaving the maternity ward. Exclusive breastfeeding allows normal growth until at least 6 months of age, and can be prolonged until the age of 2 years or more, provided that complementary feeding is started after 6 months. Breast milk contains hormones, growth factors, cytokines, immunocompetent cells, etc., and has many biological properties. The composition of breast milk is influenced by gestational and postnatal age, as well as by the moment of the feed. Breastfeeding is associated with slightly enhanced performance on tests of cognitive development. Exclusive breastfeeding for at least 3 months is associated with a lower incidence and severity of diarrhoea, otitis media and respiratory infection. Exclusive breastfeeding for at least 4 months is associated with a lower incidence of allergic disease (asthma, atopic dermatitis) during the first 2 to 3 years of life in at-risk infants (infants with at least one first-degree relative presenting with allergy). Breastfeeding is also associated with a lower incidence of obesity during childhood and adolescence, as well as with a lower blood pressure and cholesterolemia in adulthood. However, no beneficial effect of breastfeeding on cardiovascular morbidity and mortality has been shown. Maternal infection with hepatitis B and C virus is not a contraindication to breastfeeding, as opposed to HIV infection and galactosemia. A supplementation with vitamin D and K is necessary in the breastfed infant. Very few medications contraindicate breastfeeding. Premature babies can be breastfed and/or receive mother's milk and/or bank milk, provided they receive energy, protein and mineral supplements. Return to prepregnancy weight is earlier in breastfeeding mothers during the 6 months following delivery. Breastfeeding is also associated with a decreased risk of breast and ovarian cancer in the premenopausal period, and of osteoporosis in the postmenopausal period.
Subject(s)
Breast Feeding , Child Development , Diabetes Mellitus, Type 1/prevention & control , Hypersensitivity/prevention & control , Infant Nutrition Disorders/prevention & control , Mother-Child Relations , Mothers/statistics & numerical data , Obesity/prevention & control , Adult , Asthma/prevention & control , Body Mass Index , Breast Feeding/statistics & numerical data , Cognition , Depression, Postpartum/prevention & control , Dermatitis, Atopic/prevention & control , Dietary Supplements , Evidence-Based Medicine , Female , France/epidemiology , Health Promotion , Health Surveys , Humans , Infant , Prevalence , Risk Factors , World Health OrganizationABSTRACT
Protein energy malnutrition (PEM) occurs when energy and protein intake do not meet requirements. It has a functional and structural impact and increases both morbidity and mortality of a given disease. The Nutrition Committee of the French Pediatric Society recommends weighing and measuring any child when hospitalized or seen in consultation. The body mass index (BMI) must be calculated and analyzed according to references any time growth kinetics cannot be analyzed. Any child with a BMI below the third centile or -2 standard deviations for age and sex needs to be examined looking for clinical signs of malnutrition and signs orienting toward an etiology and requires having his BMI and height dynamics plotted on a chart. PEM warrants drawing up a nutritional strategy along with the overall care plan. A target weight needs to be determined as well as the quantitative and qualitative nutritional care including its implementation. This plan must be evaluated afterwards in order to adapt the nutritional therapy.
Subject(s)
Protein-Energy Malnutrition/diagnosis , Body Mass Index , Child , Humans , Mass Screening , Practice Guidelines as Topic , Prevalence , Reference ValuesABSTRACT
UNLABELLED: Lactose has beneficial nutritional effects in infancy, particularly on calcium retention and on Bifidobacterium colon microflora development. OBJECTIVE: The objective of this controlled, prospective, randomized double-blind study was to assess the adequacy and safety of an infant formula containing only lactose as carbohydrate, as compared to a usual formula. PATIENTS AND METHODS: Healthy non-breast-fed infants aged under 7 days were randomized to be fed exclusively with a conventional formula containing lactose (9.6 g/100 kcal) and maltodextrin (1.6 g/100 kcal) or the isocaloric-isoprotein study formula containing 100% lactose (11.2 g/100 kcal) for 120 days. Primary outcome was daily weight gain at D0 and D120. Weight, length, body mass index, formula consumption, tolerance, and safety were assessed monthly. The non-inferiority of the study formula was rejected if the difference in weight gain was higher than 2.5 g/day in the control group. RESULTS: One hundred and seventy-eight infants were enrolled. Mean daily weight gain in the study group differed by 0.71 g/day (95% CI: -2.23; 0.82) indicating the non-inferiority of the study formula. Growth was normal and similar in the two groups, but formula intake was decreased in the study group, leading to a decrease in energy and protein intakes. Tolerance was good and adverse events did not differ between the two groups. CONCLUSION: The 100% lactose study infant formula was safe and non-inferior to a conventional formula in ensuring normal growth during the first 4 months of life.