Sacroiliac joint involvement in children with inflammatory bowel diseases.

Objective: Sacroiliitis (SI), an inflammatory arthropathy, may accompany pediatric inflammatory bowel diseases (IBDs), present with non- specific back pain, hence might be unnoticed. The aims of this study were to assess the frequency of the SI in children with IBD and determine the characteristics of the association of SI with the clinical hallmarks of the IBD. Methods: In this prospective, cross sectional study, twenty-seven children with IBD, 7-18 years of age were evaluated. Patients with low back pain or stiffness, alternating buttock pain, or hip pain were examined for the presence of SI. The radiologic manifestations on X-ray suggesting sacroilitis were confirmed with Magnetic resonance imaging (MRI). Results: Twenty-seven children (16 girls, female/male=1.45), with mean age of 12.55±3.6 years, of which 52% had ulcerative colitis (UC), 41% had Crohn's disease (CD), and two had indeterminate colitis (IC). The median time from IBD diagnosis was 6.0 (18.0) months for patients with SI and 12.0 (13.5) months for patients without SI. Low back pain or stiffness was observed in 13 patients (48%). SI was present in eight (30%) of the children with IBD. The patients with CD were more prone to SI (45% of CD vs. 21% of UC patients). All patients with SI were negative for HLA-B27 genotyping. The disease activity and gender were not associated with increased risk for SI. MRI was remarkable for bone marrow edema in all of the patient, followed by erosions in six of them (75%), synovial enhancement observed in five (63%), and erosion associated enthesitis of the pelvic region was observed in two (25%) of the patients. Conclusion: SI may remain obscured in children with IBD. Children with CD are more prone to SI than those with UC. Pediatric rheumatology-pediatric gastroenterology collaboration might augment screening in at-risk patients.

The frequency of and factors affecting functional gastrointestinal disorders in infants that presented to tertiary care hospitals.

This study aimed to determine the prevalence of infantile functional gastrointestinal disorders (FGIDs) based on Rome IV diagnostic criteria, and to determine the associated patient demographic and nutritional characteristics. A total of 2383 infants aged 1-12 months which were evaluated by 28 general pediatricians and pediatric gastroenterologists on the same day at nine tertiary care hospitals around Istanbul, Turkey, between November 2017 and March 2018, were included in the study. Patients included consulted the pediatric outpatient clinics because of any complaints, but not for vaccines and/or routine well child follow-ups as this is not part of the activities in the tertiary care hospitals. The patients were diagnosed with FGIDs based on Rome IV diagnostic criteria. The patients were divided into a FGID group and non-FGID group, and anthropometric measurements, physical examination findings, nutritional status, risk factors, and symptoms related to FGIDs were evaluated using questionnaires. Among the 2383 infants included, 837 (35.1%) had ≥1 FGIDs, of which 260 (31%) had already presented to hospital with symptoms of FGIDs and 577 (69%) presented to hospital with other symptoms, but were diagnosed with FGIDs by a pediatrician. Infant colic (19.2%), infant regurgitation (13.4%), and infant dyschezia (9.8%) were the most common FGIDs. One FGID was present in 76%, and ≥2 FGIDs were diagnosed in 24%. The frequency of early supplementary feeding was higher in the infants in the FGID group aged ≤6 months than in the non-FGID group (P = 0.039).Conclusion: FGIDs occur quite common in infants. Since early diversification was associated with the presence of FGIDs, nutritional guidance and intervention should be part of the first-line treatment. Only 31% of the infants diagnosed with a FGID were presented because of symptoms indicating a FGID. What is Known: • The functional gastrointestinal disorders (FGIDs) are a very common disorder and affect almost half of all infants. • In infants, the frequency of FGIDs increases with mistakes made in feeding. When FGIDs are diagnosed in infants, nutritional support should be the first-line treatment. What is New: • This study shows that only a third of children presented to hospital because of the symptoms of FGIDs, but pediatricians were able to make the diagnosis in suspected infants after appropriate evaluation. • The early starting of complementary feeding (<6 months) is a risk factor for the development of FGIDs.

Significant improvement in bone mineral density in pediatric celiac disease: even at six months with gluten-free diet.

OBJECTIVES: Patients with celiac disease had significantly decreased bone mineral density even in patients with no gastrointestinal symptoms. Only few bone studies are available on pediatric patients with celiac disease. METHODS: Forty-six patients underwent measurement of areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA) before the initiation of gluten-free diet. Anthropometric, laboratory and DXA measurements at baseline and at sixth month of the treatment were compared. RESULTS: The frequency of low aBMD Z-score (≤-1 SDS) in both or any site was found to be 78.2% in this study. Of 16 patients with an aBMD Z-score of <-2 SDS five gained more than 1 SDS, and one gained more than 2 SDS. Nine of 20 patients with an aBMD Z-score of <-1 SDS completely normalized. CONCLUSIONS: The results of the study showed that low BMD is common in children with celiac disease at the time of diagnosis and could improve in a short period of six months with a strict gluten-free diet and adequate supplementation of calcium and vitamin D.

Prevalence of Helicobacter pylori among children in a training and research hospital clinic in Istanbul and comparison with Updated Sydney Classification Criteria.

OBJECTIVE: Helicobacter pylori (H. pylori) is a gram-negative bacterium and one of the reasons for gastritis, peptic and duodenal ulcers. It is a crucial public health problem for both children and adults, especially in developing countries. This study aims to investigate the prevalence of Helicobacter pylori positivity in children and to compare with updated Sydney classification criteria. METHODS: This study was conducted from January 2015 to June 2017. This study included 885 children aged 0-17 year(s). Endoscopic biopsies were evaluated for the diagnosis of infection due to H. pylori. RESULTS: The findings showed that 418 (47.2%) of 885 children were positive for H. pylori, and this positivity had a significantly increasing correlation with the presence of chronic inflammation, neutrophilic activity, lymphoid aggregates, and follicles. Erythematous pangastritis and antral nodularity on endoscopic findings had a correlation with H. pylori positivity. CONCLUSION: In this hospital-based study, the findings suggest that H. pylori infection is a problem for children and more extensive studies are needed to determine the prevalence of H. pylori positivity among children.

High-fibre enteral feeding results in improved anthropometrics and favourable gastrointestinal tolerance in malnourished children with growth failure.

AIM: The practical value of using fibre-enriched enteral feeding regimens to rehabilitate malnourished children remains inconclusive. This study determined the usage patterns, gastrointestinal tolerance, anthropometrics and safety of high-fibre enteral feeding in malnourished children with growth failure. METHODS: This Turkish observational study between February 2013 and June 2015 comprised 345 paediatric patients from 17 centres with malnutrition-related growth failure, with a weight and height of <2 SD percentiles for their age. Changes in anthropometrics, gastrointestinal symptoms, defecation habits and safety data relating to adverse events were analysed during the six-month follow-up period. RESULTS: Most subjects (99.7%) were supplemented with enteral feeding. The absolute difference and 95% confidence interval values for the Z scores of height for age, weight for age, weight for height and body mass index for height increased significantly in four months to six months to 0.21 (0.09-0.32), 0.61 (0.51-0.70), 0.81 (0.56-1.06) and 0.70 (0.53-0.86), respectively (p < 0.001 for each). The percentage of patients with normal defecation frequency significantly increased from 70.3% to 92.8% at the four months to six months visit (p = 0.004). Adverse events occurred in 15 (4.3%) of patients. CONCLUSION: Using a six-month high-fibre enteral feeding was associated with favourable outcomes in anthropometrics, appetite, gastrointestinal tolerance and safety in malnourished children.

Food allergy in children with refractory gastroesophageal reflux disease.

BACKGROUND: Gastroesophageal reflux disease (GERD) and food allergy are frequent disorders of childhood. The purpose of this study was to determine the frequency of food allergy in children with refractory GERD. METHODS: A total of 151 children resistant to pharmacologic GERD treatment underwent skin prick test, specific immunoglobulin E, eosinophil count, atopy patch test (APT), and oral food challenge, and were then divided into three groups according to the results of oral milk challenge and allergy work-up: group A1, positive oral milk challenge and positive IgE-mediated allergy test; group A2, positive milk challenge and negative IgE-mediated allergy test; and group B, negative oral milk challenge and negative allergy tests. RESULTS: There were 35, 30 and 86 patients in group A1, group A2 and group B, respectively. A total of 28 of 35 patients in group A1 had cow's milk allergy and the other seven patients had egg allergy. APT positivity was more common in group A2. Endoscopic esophagitis was observed in six group A1 patients and in four group A2 patients. Bloody stools, atopic dermatitis and recurrent wheezing episodes were significantly more common in group A1 than in group A2 and group B (P < 0.001, for both). CONCLUSION: Cow's milk allergy was observed frequently in children resistant to pharmacologic GERD treatment. Combined skin prick and specific IgE tests, APT and oral food challenge is essential for avoidance of unnecessary elimination diet.

Rare causes of gastrointestinal hemorrhage in infancy.

Gastrointestinal hemorrhage in children is a critical condition that demands quick and effective management. The differential diagnosis of gastrointestinal hemorrhage is wide. Heterotopic pancreas is a rare congenital anomaly and usually discovered incidentally. It is generally asymptomatic, but symptoms may occur when complicated by inflammation, bleeding, obstruction or malign transformation. Heterotopic pancreas may present throughout the gastrointestinal tract, but it is most commonly found in the stomach, duodenum and proximal jejunum. Juvenile polyps are common during childhood and present most often with painless rectal hemorrhage. They remain the most common colonic polyps in children. Colonoscopic polypectomy is the most effective procedure in the treatment of juvenile polyps. In this study, we describe rare causes of gastrointestinal system hemorrhage in infancy and discuss some diagnostic and therapeutic approaches.

Investigation of cardiomyopathy in children with cirrhotic and noncirrhotic portal hypertension.

BACKGROUND: Cirrhotic cardiomyopathy (CCMP) is a functional disorder characterized by electrophysiological disturbances, and diastolic and/or systolic dysfunction in patients with liver disease. This disorder is a well-defined entity in adults, but pediatric data are limited. The aim of the study was to determine the incidence, features, and risk factors of CCMP in children with portal hypertension (PHT). METHODS: This study included 50 children with cirrhotic PHT (40/50) and noncirrhotic PHT (10/50). Fifty healthy children were also selected for the control group. Electrocardiography and echocardiography were used to evaluate cardiac functions. Corrected QT (QTc) ≥ 0.45 was accepted as prolonged on electrocardiography. The study group was divided into 3 groups: cirrhotic, noncirrhotic, and control. Then, the CCMP group was created according to the diagnostic criteria. Latent CCMP was diagnosed in the presence of prolonged-QTc along with a minor criterion (tachycardia). Manifest CCMP was diagnosed in the presence of at least 2 major criteria (prolonged-QTc along with abnormal echocardiographic findings). Moreover, in this study, the risk factors for CCMP were investigated. RESULTS: The CCMP group included 10 cases (20%). Nine of these cases had latent CCMP (18%), and the remaining one (2%) had manifest CCMP. All of the cases with CCMP had cirrhosis and ascites. None of the patients with CCMP had severe cardiac symptoms, but they were already using some cardioprotective drugs such as propanolol and spironolactone. As risk factors for CCMP, pediatric end-stage liver disease scores, Child-Pugh scores, and ascites grades were found to be significant for the determination of CCMP. The most important risk factor was ascites severity (P = 0.001, odds ratio 9.4). CONCLUSIONS: Approximately 20% of children with PHT have CCMP. A detailed cardiac examination should be carried out periodically in children with cirrhotic PHT, especially in the presence of ascites and high Child-Pugh score.

A simple method for percutaneous endoscopic gastrostomy tube removal: "tie and retrograde pull".

BACKGROUND/PURPOSE: Various techniques have been presented to remove the percutaneous endoscopically placed gastrostomy tube in children, but tubes with semi-rigid internal retaining discs are difficult or impossible to remove by external traction. We describe a simple and effective endoscopic removal technique that should be applicable to any type of percutaneous endoscopic gastrostomy tube. METHODS: Percutaneous endoscopic gastrostomy tube removal was performed with the "tie and retrograde pull" technique. After a polypropylene suture was placed and tied 1cm over the skin level, the percutaneous endoscopic gastrostomy tube was cut 0.5 cm over the knot. The suture was cut from the connection point between the needle and the suture. The distal end of the suture was pushed through the stoma into the stomach. Then a forceps was inserted through the gastroscope. The suture was caught, and the residual percutaneous endoscopic gastrostomy portion was retrieved via retrograde traction on the suture. RESULTS: The causes of exchange were determined to be planned tube replacement in 9, buried bumper syndrome in 1, and tube occlusion in 3 patients. The mean tube dwell time was 10.8 ± 3.9 months. Esophageal mucosal tear developed in 1 patient with epidermolysis bullosa during removal. No other complications occurred during PEG tube exchanges. CONCLUSION: This is a rapid and useful technique that does not require any complex endoscopic devices.

Investigation of indoor molds and allergic diseases in public primary schools in Edirne city of Turkey.

BACKGROUND: Studies evaluating the role of indoor molds in the development of allergic or respiratory symptoms in schools are few in childhood. OBJECTIVE: This study aimed to investigate relation between indoor molds and allergic diseases or respiratory symptoms in primary school's children in Edirne, Turkey. METHODS: Ten public primary schools were included into the study. A thorough assessment, using a questionnaire and inspection surveys was carried out. The concentration of culturable mold was assessed in the dust samples in the schools. Indoor temperature and humidity were measured. A total of 1374 students who completed valid questionnaires were included in the study, and dust-samples were collected from the schools. RESULTS: Cumulative and current prevalence rates of wheezing, asthma, allergic rhinitis, and atopic dermatitis were found as 31.4%, 9.3%, 16.2%, 6.0% and 13.4%, 11.9%, 15.1%, 2.1%, respectively. The most frequent mold-species detected in indoor dusts were Cladosporium, Penicillium, Alternaria and Aspergillus. Although the prevalence rates of allergic diseases and respiratory symptoms were high, indoor mold amounts were low in the schools in our region and no significant correlation was determined between indoor mold amount and the prevalence of these diseases in schools or classrooms. CONCLUSION: Even though allergic molds are present in schools, the mold-exposure may not be an important predisposing factor for development of allergic and respiratory diseases the schools in our region.

Assessment of living donors with respect to pre- and posttransplant psychosocial properties and posttransplant family functioning in pediatric liver transplantation.

BACKGROUND/AIMS: We aimed in this study to investigate pre- and posttransplant clinical and psychosocial features of the donors and the effects of living-related liver transplantation and possible relevant factors on psychosocial outcome and family functioning. METHODS: Thirty-two living donors (19 females, age 31.84 ± 7.10 years) were evaluated. Medical records of donors regarding pre- and posttransplant clinical and psychological features and family life were evaluated. RESULTS: The donors were parents (n=28, 87.6%) in most. In the pretransplant evaluation, 5 donors (19.3%) had anxiety regarding postoperative complications and quality of life. Donors were discharged from the hospital in a median of 7 days (range, 5-30 days). Return to work and feeling of complete well-being were accomplished in a median of 4 weeks (range, 1-32 weeks) and 10 weeks (range, 4-48 weeks), respectively. Sixteen recipients (50.0%) suffered from major complications, and 3 (9.4%) required invasive intervention. Fourteen donors (43.4%) reported pain around the surgical incision and nonspecific gastrointestinal problems postoperatively. Psychological problems were observed in 8 donors (25.0%); 2 (6.3%) had depression requiring drug and psychotherapeutic intervention. Psychological disruption was found to be correlated with the presence of problems in the recipient (p<0.01, r=0.487). The donors' relationship with the recipient was negatively affected in 1 (3.1%), but improved in 15 (46.9%) cases. Nine donors (34.6%) displayed nervous behavior toward their spouses, and 2 (7.7%) later divorced. Life of the other family members was negatively affected in 8 (30.7%). Two donors' spouses (7.7%) failed to carry out domestic responsibilities. CONCLUSIONS: Psychological disturbance and abnormal family functioning are frequently observed during the posttransplant period. Therefore, psychologic assessment and evaluation of family functioning should be regularly repeated during the posttransplant period.

Portal gastropathy and duodenopathy in children with extrahepatic and intrahepatic portal hypertension: endoscopic diagnosis and histologic scoring.

OBJECTIVES: The aim of the study was to determine the frequency of portal gastropathy (PG) and duodenopathy (PD) in children, to document the correlation of various clinical and laboratory parameters associated with portal hypertensive gastroduodenal lesions, to compare the endoscopic portal hypertensive lesions with different histologic findings, and to evaluate the use of a possible histologic scoring system. METHODS: All children undergoing endoscopic investigation for portal hypertension (PH) between January 2006 and November 2007 were analysed retrospectively. Clinical and demographical data and endoscopic and histologic findings were recorded. Histologic findings suggestive of PG and PD (capillary dilation, increased numbers of capillaries, histologic bleeding, and edema) were scored. RESULTS: Of 51 consecutive children (29 boys, mean age 10.1 ± 3.6 years [range 2.5-15.8 years]), 28 were cirrhotic. PG was diagnosed in 58.8% endoscopically. Children with cirrhotic PH had the highest rate of PG (64.3%), whereas those with extrahepatic or intrahepatic noncirrhotic PH were alike (50% and 54.5%, respectively). Baveno PG scores were higher in children with cirrhosis with higher Child-Pugh scores. Capillary dilation was the only histologic finding showing significant association with the endoscopic diagnosis. Only 9% had PD on endoscopy. None of the histologic findings correlated with endoscopic diagnosis of PD. CONCLUSIONS: PG and PD are seen in children with extrahepatic and intrahepatic PH at rates similar to those reported in adult studies. Baveno PG scores increased in parallel with Child-Pugh class in children with cirrhosis. Capillary dilation was the only histologic finding showing significant association with the endoscopic diagnosis of PG in this study.

Human herpes virus type 8-associated Kaposi sarcoma in a pediatric liver transplant recipient.

Development of KS in pediatric liver transplant recipients is a rare entity and has dismal prognosis. Latent HHV-8 infection, immunosuppression, and genetic predisposition are possible etiological factors. Decreasing the dose or cessation of immunosuppressive drugs, switching to sirolimus with antiproliferative and antitumor properties, and different chemotherapeutic regimens are the current therapeutic strategies. We herein report a pediatric liver transplant recipient who developed generalized KS at post-transplant fifth month. The disease had an aggressive course despite the highly toxic chemotherapy. On the other hand, a prompt and durable response was provided by paclitaxel with tolerable side effects. The patient is now free of disease for at least 24 months and healthy with good graft function under sirolimus therapy as maintenance immunosuppression. Instead of highly toxic chemotherapy, paclitaxel can be used as therapeutic option in cases with generalized disease and in those who are unresponsive to conventional chemotherapy. However, new studies are needed to assess the efficacy of the paclitaxel therapy in KS in the liver transplant recipients.

Seroprevalence of autoimmune thyroiditis and celiac disease in children with insulin-dependent diabetes mellitus in the Thrace region of Turkey.

BACKGROUND/AIMS: We aimed to estimate the seroprevalence of celiac disease, a gluten-sensitive enteropathy, and autoimmune thyroiditis in children with insulin-dependent diabetes mellitus in the Thrace region of Turkey. METHODS: The population studied consisted of 33 children with insulin-dependent diabetes mellitus and 41 healthy children with demographic features similar to the study subjects. Free triiodothyronine, free thyroxine, thyroid-stimulating hormone, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, IgA, anti-endomysium IgA, and anti-gliadin IgA were measured in all cases and controls. RESULTS: The serum levels of free triiodothyronine and free thyroxine were within the normal range in all cases. However, in one patient who had anti-thyroid peroxidase and antithyroglobulin antibodies, the thyroid-stimulating hormone level was high despite a normal free triiodothyronine and free thyroxine value. Ultrasonographic findings confirmed thyroiditis in this patient. Anti-thyroid peroxidase antibodies, anti-thyroglobulin antibodies, anti-endomysium IgA and anti-gliadin IgA were detected in 15.4%, 6%, 9.1% and 3% of the diabetic cases, respectively. None of these antibodies was detected in the control group. In the diabetic group, the seroprevalences of the antithyroid peroxidase antibodies and the anti-endomysium IgA were statistically higher than in the control group (p<0.05). CONCLUSIONS: Children with insulin-dependent diabetes mellitus in our region should undergo periodic screenings for autoimmune thyroiditis and celiac disease.

The role of the non-invasive serum marker FibroTest-ActiTest in the prediction of histological stage of fibrosis and activity in children with naïve chronic hepatitis B infection.

The aim of this study was to investigate whether the non-invasive serum marker FibroTest-ActiTest (FT-AT) reliably predicts the histological stage of fibrosis and/or activity, and decreases the need for a liver biopsy. Twenty-five children with naïve chronic hepatitis B were analyzed for haptoglobin, alpha2-macroglobulin, apolipoprotein A1, bilirubin, gamma-glutamyl transferase, and alanine aminotransferase activity, and the FT-AT scores were computed. FT-AT scores were compared with histological data. FT predicted insignificant fibrosis in 14/23 (61%) patients at a cut-off level of 0.31. Nine patients (36%) had significant histological fibrosis, but none were predicted by FT. There was no correlation between FT scores and histological stage of fibrosis (r: -0.221, p = 0.228). All 4 patients with significant histological activity had corresponding significant activity in AT (100%). Fifteen out of the 19 patients (78.9%) with significant activity in AT had insignificant histological activity. At the cut-off level of 0.36, AT predicted insignificant activity in all 6 patients (100%). There was no correlation between AT scores and histological activity (r: 0.245, p = 0.237). According to histological data, 12 patients were candidates for treatment, but FT-AT did not predict 3 of them (25%). FT-AT does not appear ready for use in detecting either the stage of fibrosis or activity in children with chronic hepatitis B.

Valproic acid-associated vanishing bile duct syndrome.

Hepatotoxicity as a result of valproic acid therapy is well documented. Elevation in aminotransferase activities is rarely associated with symptoms. It sometimes manifests as acute liver failure. Here, we report a 8-year-old girl who was referred for unresolving jaundice and itching for 3 months. Past history revealed afebrile convulsion 5 months previously and beginning of valproic acid treatment. Valproic acid was discontinued after the development of jaundice. Physical examination revealed ichterus, xanthomas on extensor surfaces of extremities, and hepatomegaly without any sign of chronic liver disease. Total and direct bilirubin levels were 20.2 and 12.9 mg/dL, respectively. Enzyme activities indicating cholestasis were increased together with blood cholesterol. Tests for infectious and autoimmune, metabolic, and genetic disorders were not informative. Liver biopsy revealed portal inflammation, severe bile duct loss, and cholestasis. The patient was considered to have valproic acid-associated vanishing bile duct syndrome, which has not been reported previously.

Investigation of impaired carbohydrate metabolism in pediatric liver transplant recipients.

OGTT was performed in 28 liver transplants maintained with tacrolimus to investigate carbohydrate metabolism and assess risk factors for development of PTDM. None had PTDM that was detected by OGTT. Early PTDM in four cases (14.3%) resolved in follow-up. Five new cases (17.9%) demonstrated DCM (DCM = IGT +/- hyperinsulinemia). Fasting measurements were normal in two hyperinsulinemic cases. With one (20%, p > 0.05) exception none of the children with DCM were overweight or had a family history of diabetes. All five (100%) children with DCM had been given high cumulative dosage of steroids 18 (78.3%)--without DCM (p > 0.05). The median age of children with DCM was greater [4.3 (12.7-18.0) vs. 7.0 (2.3-18.0) yr, p < 0.01] and duration of follow-up longer [5.3 (2.3-7.0) vs. 2.5 (0.7-7.3) yr, p < 0.05]. Four children (80%) with DCM were pubertal (p < 0.05). However, neither age nor duration of follow-up or pubertal stage had significant effect on DCM development. Early PTDM is a transient phenomenon and is not predictive for future development of diabetes. DCM is frequently observed in liver transplanted children. Albeit the children with DCM were given high cumulative dose of steroids, were older, mostly were pubertal, and had longer duration of follow-up, we cannot draw firm conclusions on effects of the risk factors on carbohydrate metabolism because of the small sample size and relatively short duration of follow-up. Unlike fasting measurements, OGTT can detect all children with DCM.

The comparison of single-dose ceftriaxone, five-day azithromycin, and ten-day amoxicillin/clavulanate for the treatment of children with acute otitis media.

The aim of the study was to evaluate the efficacy of short-course antimicrobial therapies [single intramuscular dose of ceftriaxone (50 mg/kg, not exceeding 1 g), 5 days of azithromycin (10 mg/kg on day 1, then 5 mg/kg daily on days 2-5) and the traditional 10-day course of amoxicillin/clavulanate (90/6.4 mg/kg/day in 2 doses)] in children with acute otitis media (AOM). The study was conducted as a prospective, comparative, open randomized trial between February 2001 and April 2003, and 104 children were enrolled, with a mean age of 3.8 (2.3) years. The clinical and otoscopic assessments of the children were made on days 0, 3, 11 and 30 after admission, and tympanometry was performed on day 30. The patients were diagnosed and followed with a scoring system. Clinical success was achieved in 29/34 patients (85.3%) in the ceftriaxone group, 27/31 patients (87.1%) in the azithromycin group and 34/39 children (87.2%) in the amoxicillin/clavulanate group. The rate of persistence of middle-ear fluid did not differ between the three groups (p>0.05). During the one-month period, no recurrent case was observed. The most common drug-related adverse effects were associated with the gastrointestinal system. In conclusion, for the treatment of children with AOM, the clinical success of single-dose intramuscular ceftriaxone and of five-day azithromycin treatments was comparable to that of the traditional 10-day therapy with high-dose amoxicillin/clavulanate.