PURPOSE: Regurgitation is a common physiological phenomenon in infants. The aim of the present study was to evaluate the efficacy of a new anti-regurgitation (AR) formula (Novalac), thickened with an innovative complex including fibres, on the daily number of regurgitations and to assess its impact on stool consistency and frequency. METHODS: Infants younger than five months, presenting at least 5 regurgitations per day were recruited in this trial. The efficacy of the new formula on regurgitation (daily number and Vandenplas score), stool frequency and consistency were assessed at day 14 and 90. Growth data were recorded at each study visit. RESULTS: Ninety babies (mean age 9.6±5.8 weeks) were included in the full analysis data set. The mean number of regurgitation episodes at inclusion was 7.3±3.4. In all infants, regurgitations improved after 2 weeks. The daily number of regurgitations decreased significantly (-6.3±3.3, p<0.001) including in those previously fed a thickened formula (-6.2±3.0, p<0.001). There was no significant change in stool consistency at day 14. After 3 months, 97.5% of infants had formed or soft stools. Growth was appropriate with a slight increase of weight-for-age z-score (from -0.5±1.0 to -0.1±0.9) and no change of weight-for length z-score (-0.1±1.1 to -0.1±-1.1). CONCLUSION: The new AR formula thickened with an innovative complex is very effective in reducing the daily number of regurgitations without having a negative impact on stools consistency.
Dataset ; Gastroesophageal Reflux ; Humans ; Infant ; Infant Formula ; Physiological Phenomena

A 4-week-old infant presented with a coagulation disorder resulting from a vitamin K deficiency. The vitamin K deficiency was caused by neonatal cholestasis due to biliary atresia. Jaundice, hepatomegaly and pale stools are the predominant presenting symptoms of biliary atresia, none of which were recognized in our patient before admission. However, the patient presented with bleeding caused by vitamin K deficiency. She was fully breastfed and had received adequate doses of vitamin K at birth and from the age of 1 week. In case of a hemorrhagic diathesis due to neonatal cholestasis, timely identification of treatable underlying disorders, in particular biliary atresia, is important because an early surgical intervention results in a better prognosis. Meticulous history taking and a thorough physical exam can be decisive for an early diagnosis and subsequent intervention.
Biliary Atresia ; Cholestasis* ; Early Diagnosis ; Hemorrhage ; Hemorrhagic Disorders* ; Hepatomegaly ; Humans ; Infant ; Jaundice ; Parturition ; Prognosis ; Vitamin K ; Vitamin K Deficiency

Esophageal strictures are seldom in children. In many countries, accidental ingestion of corrosives is a major cause of risk for stricture formation. Therefore, their management is a challenge. Safety and long-term efficacy of esophageal dilation for benign esophageal strictures has been confirmed in children. Because most children with structures are toddlers or younger, balloon dilatation is often preferred over bouginage. There is increasing evidence that short duration administration of high doses steroids may be of benefit in some specific situation (IIb esophagitis according to Zargar classification). Mytomycin-C application needs to be further evaluated. Stenting was reported to be successful in some refractory cases.
Caustics ; Child* ; Constriction, Pathologic* ; Dilatation ; Eating ; Esophagitis ; Humans ; Mitomycin ; Stents ; Steroids

Esophageal strictures are seldom in children. In many countries, accidental ingestion of corrosives is a major cause of risk for stricture formation. Therefore, their management is a challenge. Safety and long-term efficacy of esophageal dilation for benign esophageal strictures has been confirmed in children. Because most children with structures are toddlers or younger, balloon dilatation is often preferred over bouginage. There is increasing evidence that short duration administration of high doses steroids may be of benefit in some specific situation (IIb esophagitis according to Zargar classification). Mytomycin-C application needs to be further evaluated. Stenting was reported to be successful in some refractory cases.
Caustics ; Child* ; Constriction, Pathologic* ; Dilatation ; Eating ; Esophagitis ; Humans ; Mitomycin ; Stents ; Steroids

PURPOSE: To compare the effectiveness of the magnesium (Mg)-enriched formula vs. control formula in constipated infants. METHODS: An open-label, interventional, and the comparator-controlled study was conducted to evaluate the effectiveness of the Mg-enriched formula in formula-fed infants ≤6 months old presenting with functional constipation according to modified Rome IV criteria. Infants were randomized 1:1 to intervention or control formula for 30 days. Parents recorded stool consistency (hard, normal, or watery) and frequency on days 1–7 and 23–29. Physicians recorded patient baseline characteristics and performed the clinical examination at the time of three patient visits (baseline, day 8, and 30). RESULTS: Of the 286 recruited infants, 143 received the Mg-rich formula and 142 received the control formula. After 7 days, significantly more infants had stools with normal consistency with the Mg-rich formula compared to the infants fed with the control formula (81.8% vs. 41.1%; p<0.001). The number of infants passing one or more stools per day was increased at day 7 in the Mg-rich formula group (86.7% vs. 68.2%; p<0.001). At days 7 and 29, >25% of infants responded completely to the Mg-rich formula compared to <5% of infants fed with the control formula (p<0.001). Parents of infants in the Mg-rich formula group were very satisfied with the treatment (80.8% vs. 10.2%), with the majority willing to continue treatment after 30 days (97.9% vs. 52.6%; p<0.001). CONCLUSION: The Mg-rich formula significantly improved stool consistency and frequency compared to the control formula in constipated infants.
Constipation ; Defecation ; Humans ; Infant Formula ; Infant ; Magnesium ; Nutrition Therapy ; Parents

Purpose: The Cow's Milk-related Symptom Score (CoMiSS™) was developed as an awareness tool for evaluating cow's milk-related symptoms in otherwise healthy children. Using a convenience sample of participants, this cross-sectional study aimed to determine CoMiSS™ values of symptomatic infants based on retrospectively or prospectively obtained information. Methods: CoMiSS™ values were determined in infants aged <12 months with symptoms suggestive of cow's milk protein allergy or functional gastrointestinal disorders. The exclusion criteria were previous diagnosis with acute or chronic disease, treatment with a therapeutic formula, and in case of breastfeeding, an elimination diet followed by the mother. Two CoMiSS™ values were assessed. A retrospective collection was defined as the collection of data after initial contact with the medical center but before the first medical consultation. A prospective collection was defined as the collection of data within 24 hours from the time of medical consultation but before starting any therapeutic intervention. The CoMiSS™ total and individual component scores obtained retrospectively or prospectively were compared between groups using the Wilcoxon signed-rank test. Results: This study was performed between August and November 2019. Data of 110 children (62 males and 48 females), with a mean±standard deviation age of 18.2±11.7 weeks, were obtained. The total CoMiSS™ value (p<0.001) and some individual component scores (crying, regurgitation, and stool) were significantly lower when collected prospectively than when collected retrospectively. Conclusion CoMiSS™ values were retrospectively and prospectively determined. Lower CoMiSS™ values were obtained during prospective evaluation. Possible differences should be considered when using CoMiSS™ in clinical practice.

Purpose: The Cow's Milk-related Symptom Score (CoMiSS™) was developed as an awareness tool for evaluating cow's milk-related symptoms in otherwise healthy children. Using a convenience sample of participants, this cross-sectional study aimed to determine CoMiSS™ values of symptomatic infants based on retrospectively or prospectively obtained information. Methods: CoMiSS™ values were determined in infants aged <12 months with symptoms suggestive of cow's milk protein allergy or functional gastrointestinal disorders. The exclusion criteria were previous diagnosis with acute or chronic disease, treatment with a therapeutic formula, and in case of breastfeeding, an elimination diet followed by the mother. Two CoMiSS™ values were assessed. A retrospective collection was defined as the collection of data after initial contact with the medical center but before the first medical consultation. A prospective collection was defined as the collection of data within 24 hours from the time of medical consultation but before starting any therapeutic intervention. The CoMiSS™ total and individual component scores obtained retrospectively or prospectively were compared between groups using the Wilcoxon signed-rank test. Results: This study was performed between August and November 2019. Data of 110 children (62 males and 48 females), with a mean±standard deviation age of 18.2±11.7 weeks, were obtained. The total CoMiSS™ value (p<0.001) and some individual component scores (crying, regurgitation, and stool) were significantly lower when collected prospectively than when collected retrospectively. Conclusion CoMiSS™ values were retrospectively and prospectively determined. Lower CoMiSS™ values were obtained during prospective evaluation. Possible differences should be considered when using CoMiSS™ in clinical practice.

Antibiotics are frequently administered during pregnancy. Although necessary to address acute infections, their use facilitates antibiotic resistance. Other associations have also been found with the use of antibiotics, such as perturbations of gut bacteria, delays in microbial maturation, and increased risks of allergic and inflammatory diseases. Little is known about how the prenatal and perinatal administration of antibiotics to mothers affects the clinical outcomes of their offspring. A literature search was conducted of the Cochrane, Embase, and PubMed engines. The retrieved articles were reviewed by two authors and verified for relevance. The primary outcome was the effect of pre- and perinatal maternal antibiotic use on clinical outcomes. Thirty-one relevant studies were included in the meta-analysis. Various aspects are discussed, including infections, allergies, obesity, and psychosocial factors. In animal studies, antibiotic intake during pregnancy has been suggested to cause longterm alterations in immune regulation. In humans, associations have been found between antibiotic intake during pregnancy and different types of infections and an increased risk of pediatric infection–related hospitalization. A dose-dependent positive association between pre- and perinatal antibiotic use and asthma severity has been reported in animal and human studies, while positive associations with atopic dermatitis and eczema were reported by human studies. Multiple associations were identified between antibiotic intake and psychological problems in animal studies; however, relevant data from human studies are limited. However, one study reported a positive association with autism spectrum disorders. Multiple animal and human studies reported a positive association between preand perinatal antibiotic use by mothers and diseases in their offspring. Our findings have potentially significant clinical relevance, particularly considering the implications for health during infancy and later in life as well as the related economic burden.

The diagnosis and treatment of cow's milk protein allergy (CMPA) is still a challenge. A systematic literature search was performed using Embase, Medline, The Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Clinical Trials for the diagnosis and treatment of cow's milk allergy (CMA). Since none of the symptoms of CMPA is specific and since there is no sensitive diagnostic test (except a challenge test), the diagnosis of CMPA remains difficult. A "symptom-based score" is useful in children with symptoms involving different organ systems. The recommended dietary treatment is an extensive cow milk based hydrolysate. Amino acid based formula is recommended in the most severe cases. However, soy infant formula and hydrolysates from other protein sources (rice) are gaining popularity, as they taste better and are cheaper than the extensive cow's milk based hydrolysates. Recent meta-analyses confirmed the safety of soy and estimate that not more than 10-15% of CMPA-infants become allergic to soy. An accurate diagnosis of CMA is still difficult. The revival of soy and the development of rice hydrolysates challenge the extensive cow's milk based extensive hydrolysates as first option and amino acid formula.
Child ; Diagnosis ; Diagnostic Tests, Routine ; Humans ; Hypersensitivity* ; Infant ; Infant Formula ; Milk Hypersensitivity ; Milk Proteins* ; Milk*

Table 2 contains a typographical error.
Consensus* ; Diagnosis* ; Hypersensitivity* ; Middle East* ; Milk Proteins*