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BACKGROUND AND OBJECTIVES: Hospital readmission rate helps to highlight the effectiveness of post-discharge care. There remains a paucity of plausible age-based categorization especially for ages below one year for hospital readmission rates. METHODS: Data from the 2017 Healthcare Cost and Utilization Project National Readmissions Database was analyzed for ages 0-18 years. Logistic regression analysis was performed to identify predictors for unplanned early readmissions. Results: We identified 5,529,389 inpatient pediatric encounters which were further divided into age group cohorts. The overall rate of readmissions was identified at 3.2%. Beyond infancy, the readmission rate was found to be 6.7%. Across all age groups, the major predictors of unplanned readmission were cancers, diseases affecting transplant recipients and sickle cell patients. It was determined that reflux, milk protein allergy, hepatitis and inflammatory bowel diseases were significant diagnoses leading to readmission. Anxiety, depression and suicidal ideation depicted higher readmission rates in those older than 13 years. Across ages one to four years, dehydration, asthma and bronchiolitis were negative predictors of unplanned readmission. Conclusions: Thirty-day unplanned readmissions remain a problem leading to billions of taxpayer dollars lost per annum. Effective strategies for mandatory outpatient follow-up may help the financial aspect of care while also enhancing the quality of care.
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In 2016, the American Academy of Pediatrics published a clinical practice guideline that more specifically defined apparent life-threatening events as brief resolved unexplained events (BRUEs) and provided evidence-based recommendations for the evaluation of infants who meet lower-risk criteria for a subsequent event or serious underlying disorder. The clinical practice guideline did not provide recommendations for infants meeting higher-risk criteria, an important and common population of patients. Therefore, we propose a tiered approach for clinical evaluation and management of higher-risk infants who have experienced a BRUE. Because of a vast array of potential causes, the initial evaluation prioritizes the diagnosis of time-sensitive conditions for which delayed diagnosis or treatment could impact outcomes, such as child maltreatment, feeding problems, cardiac arrhythmias, infections, and congenital abnormalities. The secondary evaluation addresses problems that are less sensitive to delayed diagnosis or treatment, such as dysphagia, intermittent partial airway obstruction, and epilepsy. The authors recommend a tailored, family-centered, multidisciplinary approach to evaluation and management of all higher-risk infants with a BRUE, whether accomplished during hospital admission or through coordinated outpatient care. The proposed framework was developed by using available evidence and expert consensus.
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Diagnóstico Tardio/tendências , Hospitalização/tendências , Sintomas Inexplicáveis , Diagnóstico Tardio/prevenção & controle , Humanos , Recém-Nascido , Fatores de RiscoRESUMO
BACKGROUND: In gastroesophageal reflux disease (GERD), the frequency of heartburn symptoms and erosive esophagitis (EE) increases with age in children and adolescents. Proton pump inhibitor, dexlansoprazole, is approved for healing EE of all grades, maintenance of healed EE, relief of heartburn, and treatment of symptomatic non-erosive GERD in patients ≥ 12 years. AIM: To assess safety and efficacy of dexlansoprazole dual delayed-release capsule in healing of EE and maintenance of healed EE in adolescents. METHODS: A multicenter, phase 2, 36-week study was conducted in 62 adolescents (12-17 years) with endoscopically confirmed EE. Patients received dexlansoprazole 60 mg once daily (QD) during open-label healing phase. Those with confirmed healing at week 8 were randomized to dexlansoprazole 30 mg QD or placebo during 16-week, double-blind maintenance phase, with subsequent treatment-free follow-up of ≥ 12 weeks. Primary endpoints were treatment-emergent adverse events (TEAEs) in ≥ 5% of patients during treatment. Secondary endpoints included percentages of patients with healing of EE and with maintenance of healed EE. RESULTS: 88% of patients achieved EE healing, and 61.3% reported a TEAE [headache (12.9%), oropharyngeal pain (8.1%), diarrhea (6.5%), and nasopharyngitis (6.5%)]. During maintenance phase, healing was maintained in 82% and 58% of dexlansoprazole and placebo groups, respectively. 72.0% of dexlansoprazole-treated patients reported TEAEs, which included headache (24.0%), abdominal pain (12.0%), nasopharyngitis (12.0%), pharyngitis (12.0%), sinusitis (12.0%), bronchitis (8.0%), upper respiratory tract infection (8.0%), and insomnia (8.0%); 61.5% experienced a TEAE with placebo. CONCLUSIONS: Dexlansoprazole is safe and efficacious for healing EE and maintenance of healed EE in adolescents.
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Dexlansoprazol/uso terapêutico , Esofagite Péptica/tratamento farmacológico , Refluxo Gastroesofágico/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêutico , Dor Abdominal/induzido quimicamente , Adolescente , Criança , Preparações de Ação Retardada , Diarreia/induzido quimicamente , Método Duplo-Cego , Feminino , Cefaleia/induzido quimicamente , Humanos , Quimioterapia de Manutenção , Masculino , Nasofaringite/induzido quimicamente , Orofaringe , Dor/induzido quimicamente , Faringite/induzido quimicamente , Distúrbios do Início e da Manutenção do Sono/induzido quimicamente , Resultado do TratamentoRESUMO
OBJECTIVE: The aim of this prospective cross sectional study was to assess the prevalence of sleep disturbance in children with inflammatory bowel disease (IBD), including the relationships between sleep, inflammatory markers, and disease activity of pediatric patients with IBD. METHODS: Pediatric patients with IBD and parents were enrolled in the study. Patients completed the Pittsburgh Sleep Quality Index (PSQI), the Pediatric Daytime Sleepiness Scale, and the Adolescent Sleep Wake Scale (ASWS) surveys. Parents completed the Child Sleep Habits Questionnaire (CSHQ). Disease activity for Crohn disease (CD) was determined by the Pediatric Crohn Disease Activity Index and the Pediatric Ulcerative Colitis Activity Index was used to define disease activity in ulcerative colitis (UC)/indeterminate colitis patients. RESULTS: Fifty-three pediatric patients with IBD (38 CD, 12 UC, and 3 indeterminate colitis) participated in the study. The significant correlations between the CSHQ and Pediatric Crohn Disease Activity Index (Pâ=â0.002) and the PSQI and Pediatric Ulcerative Colitis Activity Index (Pâ=â0.04) were found. Youth with UC and indeterminate colitis significantly reported more sleep disturbance than patients with CD, (Pâ=â0.03, 0.05, and 0.04; PSQI, Pediatric Daytime Sleepiness Scale, ASWS, respectively). Patients self-reported significantly more sleep disturbance than was observed by parents (Pâ<â0.0001). This study showed the significant correlations between CSHQ score compared to erythrocyte sedimentation rate and albumin (Pâ=â0.001 and 0.03, respectively). CONCLUSIONS: Results suggest that increased disease activity is associated with adverse effects on sleep quality. Based on the results of this study, pediatric patients with IBD should be screened for sleep disturbance.
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Colite Ulcerativa/complicações , Doença de Crohn/complicações , Doenças Inflamatórias Intestinais/complicações , Índice de Gravidade de Doença , Transtornos do Sono-Vigília/epidemiologia , Adolescente , Criança , Pré-Escolar , Colite Ulcerativa/fisiopatologia , Doença de Crohn/fisiopatologia , Estudos Transversais , Feminino , Humanos , Doenças Inflamatórias Intestinais/fisiopatologia , Masculino , Prevalência , Estudos Prospectivos , Sono , Transtornos do Sono-Vigília/etiologia , Inquéritos e QuestionáriosRESUMO
Clostridium difficile infection is increasingly diagnosed in children with a wide clinical spectrum ranging from asymptomatic carriage to fulminant colitis. Symptomatic patients typically present with diarrhea, with or without blood, fever, and abdominal pain. Kawasaki disease, a vasculitis of unknown etiology, occurs primarily in young children. Establishing the diagnosis of Kawasaki disease can be challenging given the lack of a confirmatory diagnostic test or pathognomonic features as well as the appearance of symptoms over time rather than simultaneously. In addition, commonly occurring nonspecific associated symptoms, such as diarrhea and abdominal pain, may confound the clinical presentation. We present two cases of children with Kawasaki disease presenting with fever and Clostridium difficile colitis to illustrate the importance of keeping a high index of suspicion for Kawasaki disease.
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INTRODUCTION: A brief resolved unexplained event (BRUE) describes an event associated with a change in muscle tone, color, respiration, and responsiveness that is unexplained after an appropriate examination. Some infants with higher risk BRUE may undergo endoscopy as part of their evaluation. OBJECTIVE: This retrospective study aimed to identify the endoscopic findings in infants who have experienced a higher risk BRUE. We also compared the characteristics, prenatal, natal, and postnatal risk factors between 23 infants who underwent endoscopic evaluation and 23 race-matched/sex-matched/term-matched/preterm-matched infants who did not undergo endoscopic evaluation. METHODS: This was a retrospective descriptive study. Infants were identified from a query of medical records using the ICD-10 code for BRUE (R68.13). RESULTS: Of 119 infants with BRUE, 23 infants with higher risk BRUE underwent an esophagogastroduodenoscopy and flexible sigmoidoscopy. Apnea (87%) was the most common presentation of BRUE. Most were female (57%) with a mean age at BRUE presentation of 2.73 months. We found 10 (43.5%) term infants and 13 (56.5%) preterm infants in our study. There were no significant differences in characteristics, prenatal, natal, and postnatal risk factors between the infants who underwent endoscopy and those who did not undergo endoscopy. The most common abnormal endoscopic finding was lymphonodular hyperplasia (LNH) associated with eosinophilia in the rectosigmoid colon. The proportion of females in the LNH group was significantly higher than the non-LNH group. CONCLUSION: Rectosigmoid LNH and eosinophilia, which are associated with milk soy protein intolerance (MSPI), were the most common findings on endoscopic evaluation. Although there is no proof of causation between MSPI and BRUE, MSPI should be considered in the differential diagnosis for higher risk BRUE.
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Endoscopia Gastrointestinal , Eosinofilia/patologia , Mucosa Intestinal/patologia , Tecido Linfoide/patologia , Sintomas Inexplicáveis , Doenças do Colo Sigmoide/patologia , Obstrução das Vias Respiratórias/etiologia , Apneia/etiologia , Cianose/etiologia , Eosinofilia/diagnóstico por imagem , Feminino , Engasgo , Humanos , Hiperplasia/diagnóstico por imagem , Lactente , Recém-Nascido , Masculino , Estudos Retrospectivos , Fatores de Risco , Doenças do Colo Sigmoide/diagnóstico por imagem , SigmoidoscopiaRESUMO
BACKGROUND: Brief Resolved Unexplained Events (BRUE) is defined as a sudden, brief and now resolved episode characterized by color change, altered respirations, change in tone, and altered level of responsiveness. This study aims to identify the characteristics of esophageal Multichannel Intraluminal Impedance-pH (MII-pH) monitoring in infants who have experienced a BRUE. METHODS: This study was a retrospective review of records of infants younger than 12 months who presented to the University of South Alabama Children's and Women's Hospital with an admission diagnosis of BRUE. Patients who underwent esophageal MII-pH monitoring between October 2015 and February 2017 and diagnosed with BRUE were initially included in this study. RESULTS: Fifty-three infants (preterm 25, term 28) who experienced a higher risk BRUE were included in our study. The mean age at diagnosis was 2.25 ± 2.07 months. Apnea (41/53; 77.4%) was the most common manifestation of BRUE. Non-acid reflux events were the most common findings in the MII-pH studies (66%). MII-pH results showed 6/53 (11%) acid reflux, 17/53 (32%) non-acid reflux and 12/53 (23%) both acid/nonacid reflux and 18/53 (34%) were normal. There were significant differences in the longest acid reflux episode and the Reflux Symptom Sensitivity Index (RSSI) of coughing/choking/gagging between preterm and term infants. The Reflux Symptom Index (RSI), RSSI and Reflux Symptom Association Probability (RSAP) were significantly correlated with each other in all symptoms (pain/fussiness, coughing/choking/gagging and vomiting). CONCLUSIONS: Among infants experiencing a higher risk BRUE, esophageal MII-pH monitoring revealed acid or nonacid reflux in 2/3 of patients.
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BACKGROUND: Pediatric patients with inflammatory bowel disease (IBD) are at risk for psychiatric symptoms that impact quality of life (QoL) and psychosocial functioning. Sleep disturbance has been reported to impose adverse effects on host defense mechanisms by affecting the magnitude and characteristics of the inflammatory response. The current study sought to assess the relationships among sleep disturbance, QoL, and psychosocial functioning in children with IBD. METHODS: Pediatric IBD patients completed multiple measures of sleep and daytime functioning as well as measures of QoL and psychosocial functioning. The parents completed complementary measures of sleep, QoL, and psychosocial functioning. The HRQOL results for subjects with IBD were compared to a healthy control group. RESULTS: Fifty-three children with pediatric IBD and their parents were enrolled in the study. QoL was positively associated with sleep quality, based on significant negative correlations between QoL and both sleep quality and daytime sleepiness scales (r = -0.62, -0.57; p value <0.001, respectively). Patients with CD reported significantly better QoL and psychosocial functioning than patients with UC. The QoL was similar between IBD patients and healthy controls. CONCLUSIONS: The present study suggests that a positive association exists between sleep functioning and QoL in pediatric patients with IBD. Patients with pediatric IBD should be screened for sleep disturbance, QoL and psychosocial functioning. Prevention and intervention strategies of sleep disturbance aimed at improving QoL and psychosocial functioning in children with IBD should be developed and evaluated.
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BACKGROUND: Esophageal multichannel intraluminal impedance-pH monitoring has become one of the preferred tests to correlate observed reflux-like behaviors with esophageal reflux events. The Gastroesophageal reflux disease Assessment Symptom Questionnaire is a validated tool used to distinguish infants with gastroesophageal reflux disease from healthy children. The aim of this study was to determine whether the Gastroesophageal reflux disease Assessment Symptom Questionnaire composite symptom scores and individual symptom scores correlate with outcomes in esophageal multichannel intraluminal impedance-pH monitoring. METHODS: A total of 26 patients with gastroesophageal reflux disease-associated symptoms, aged 0-2 years, for whom both esophageal multichannel intraluminal impedance-pH monitoring and Gastroesophageal reflux disease Assessment Symptom Questionnaire survey results were available were included in the study. Gastroesophageal reflux disease Assessment Symptom Questionnaire score data were collected from a 7-day recall of parent's responses about the frequency and severity of gastroesophageal reflux disease symptoms, which determined the individual symptom scores. The composite symptom scores is the sum of all individual symptom scores. Multichannel intraluminal impedance-pH study results were compared to Gastroesophageal reflux disease Assessment Symptom Questionnaire data using Pearson correlation. RESULTS: Among 26 patients, a total number of 2817 (1700 acid and 1117 non-acid) reflux episodes and 845 clinical reflux behaviors were recorded. There were significant correlations between the reflux index and the individual symptom scores for coughing/gagging/choking (r2 = 0.2842, p = 0.005), the impedance score and individual symptom scores for coughing/gagging/choking (r2 = 0.2482, p = 0.009), the reflux symptom index for acid reflux-related coughing/gagging/choking and the individual symptom scores for coughing/gagging/choking (r2 = 0.1900, p = 0.026), the impedance score and individual symptom scores for vomiting (r2 = 0.1569, p = 0.045), and the impedance score and the composite symptom scores (r2 = 0.2916, p = 0.004). However, there were no significant correlations between fussiness, irritability, or abdominal pain-related multichannel intraluminal impedance-pH results and the individual symptom scores for abdominal pain. CONCLUSION: The impedance scores from multichannel intraluminal impedance-pH studies correlate with coughing/gagging/choking and vomiting in infants with gastroesophageal reflux disease. There are no significant correlations among the reflux index and impedance score versus the Gastroesophageal reflux disease Assessment Symptom Questionnaire scores for abdominal pain. We conclude that in infants with gastroesophageal reflux disease, multichannel intraluminal impedance-pH studies are more likely to demonstrate an association between gastroesophageal reflux disease and symptoms of coughing, gagging, or choking compared to an association between gastroesophageal reflux disease and pain in infants.
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BACKGROUND: Proton pump inhibitors are commonly used to treat gastro-esophageal reflux disease (GERD) and nonerosive GERD (NERD) in adolescents and adults. Despite the efficacy of available medications, many patients have persisting symptoms, indicating a need for more effective agents. AIMS: To assess the safety and efficacy of dexlansoprazole dual delayed-release capsules in adolescents for treatment of symptomatic NERD. METHODS: A phase 2, open-label, multicenter study was conducted in adolescents aged 12-17 years. After a 21-day screening period, adolescents with endoscopically confirmed NERD received a daily dose of 30-mg dexlansoprazole for 4 weeks. The primary endpoint was treatment-emergent adverse events (TEAEs) experienced by ≥5% of patients. The secondary endpoint was the percentage of days with neither daytime nor nighttime heartburn. Heartburn symptoms and severity were recorded daily in patient electronic diaries and independently assessed by the investigator, along with patient-reported quality of life, at the beginning and end of the study. RESULTS: Diarrhea and headache were the only TEAEs reported by ≥5% of patients. Dexlansoprazole-treated patients (N = 104) reported a median 47.3% of days with neither daytime nor nighttime heartburn. Symptoms such as epigastric pain, acid regurgitation, and heartburn improved in severity for 73-80% of patients. Pediatric Gastroesophageal Symptom and Quality of Life Questionnaire-Adolescents-Short Form symptom and impact subscale scores (scaled 1-5) each decreased by an average of 0.7 units at week 4. CONCLUSIONS: Use of 30-mg dexlansoprazole in adolescent NERD was generally well tolerated and had beneficial effects on improving heartburn symptoms and quality of life. TRIAL REGISTRATION: This study has the ClinicalTrials.gov identifier NCT01642602.
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Dexlansoprazol/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Azia/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêutico , Administração Oral , Adolescente , Idade de Início , Cápsulas , Criança , Preparações de Ação Retardada , Dexlansoprazol/administração & dosagem , Dexlansoprazol/efeitos adversos , Europa (Continente) , Feminino , Refluxo Gastroesofágico/diagnóstico , Azia/diagnóstico , Humanos , América Latina , Masculino , América do Norte , Inibidores da Bomba de Prótons/administração & dosagem , Inibidores da Bomba de Prótons/efeitos adversos , Qualidade de Vida , Indução de Remissão , Índice de Gravidade de Doença , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
Autoimmune hepatitis (AIH) is a progressive liver disease that is often associated with extrahepatic autoimmune disorders. Evans syndrome (ES) is a rare autoimmune disorder, which is characterized by immune thrombocytopenia and autoimmune hemolytic anemia. Association of AIH with ES is rare, especially in children. We report a 3-year-old female with a past medical history of ES who presented with jaundice and significant transaminitis due to AIH type 1. She required multiple treatments with steroids as well as azathioprine, intravenous immunoglobulin and a course of rituximab.
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This is the first clinical practice guideline from the American Academy of Pediatrics that specifically applies to patients who have experienced an apparent life-threatening event (ALTE). This clinical practice guideline has 3 objectives. First, it recommends the replacement of the term ALTE with a new term, brief resolved unexplained event (BRUE). Second, it provides an approach to patient evaluation that is based on the risk that the infant will have a repeat event or has a serious underlying disorder. Finally, it provides management recommendations, or key action statements, for lower-risk infants. The term BRUE is defined as an event occurring in an infant younger than 1 year when the observer reports a sudden, brief, and now resolved episode of ≥1 of the following: (1) cyanosis or pallor; (2) absent, decreased, or irregular breathing; (3) marked change in tone (hyper- or hypotonia); and (4) altered level of responsiveness. A BRUE is diagnosed only when there is no explanation for a qualifying event after conducting an appropriate history and physical examination. By using this definition and framework, infants younger than 1 year who present with a BRUE are categorized either as (1) a lower-risk patient on the basis of history and physical examination for whom evidence-based recommendations for evaluation and management are offered or (2) a higher-risk patient whose history and physical examination suggest the need for further investigation and treatment but for whom recommendations are not offered. This clinical practice guideline is intended to foster a patient- and family-centered approach to care, reduce unnecessary and costly medical interventions, improve patient outcomes, support implementation, and provide direction for future research. Each key action statement indicates a level of evidence, the benefit-harm relationship, and the strength of recommendation.
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Apneia/diagnóstico , Cianose/diagnóstico , Hipotonia Muscular/diagnóstico , Terminologia como Assunto , Emergências , Humanos , Lactente , Fatores de Risco , Morte Súbita do Lactente/diagnósticoRESUMO
Recent comprehensive guidelines developed by the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition define the common entities of gastroesophageal reflux (GER) as the physiologic passage of gastric contents into the esophagus and gastroesophageal reflux disease (GERD) as reflux associated with troublesome symptoms or complications. The ability to distinguish between GER and GERD is increasingly important to implement best practices in the management of acid reflux in patients across all pediatric age groups, as children with GERD may benefit from further evaluation and treatment, whereas conservative recommendations are the only indicated therapy in those with uncomplicated physiologic reflux. This clinical report endorses the rigorously developed, well-referenced North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition guidelines and likewise emphasizes important concepts for the general pediatrician. A key issue is distinguishing between clinical manifestations of GER and GERD in term infants, children, and adolescents to identify patients who can be managed with conservative treatment by the pediatrician and to refer patients who require consultation with the gastroenterologist. Accordingly, the evidence basis presented by the guidelines for diagnostic approaches as well as treatments is discussed. Lifestyle changes are emphasized as first-line therapy in both GER and GERD, whereas medications are explicitly indicated only for patients with GERD. Surgical therapies are reserved for children with intractable symptoms or who are at risk for life-threatening complications of GERD. Recent black box warnings from the US Food and Drug Administration are discussed, and caution is underlined when using promoters of gastric emptying and motility. Finally, attention is paid to increasing evidence of inappropriate prescriptions for proton pump inhibitors in the pediatric population.
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Fundoplicatura/métodos , Refluxo Gastroesofágico/diagnóstico , Refluxo Gastroesofágico/terapia , Guias de Prática Clínica como Assunto , Inibidores da Bomba de Prótons/uso terapêutico , Adolescente , Fatores Etários , Criança , Pré-Escolar , Dietoterapia/métodos , Gerenciamento Clínico , Monitoramento do pH Esofágico , Esofagoscopia/métodos , Feminino , Humanos , Lactente , Masculino , Prognóstico , Medição de Risco , Índice de Gravidade de Doença , Resultado do TratamentoRESUMO
BACKGROUND: Childhood lead poisoning continues to be a public health problem; however, lead screening rates remain low in many areas. Our objective is to increase screening in pediatric clinics, while testing a questionnaire for its predictability of elevated blood lead levels (BLLs). METHODS: Participants were approached at pediatric clinics in Las Vegas, Nevada. A brief questionnaire assessed the child's potential exposure to lead and a blood sample was collected from each child. RESULTS: Of 564 children tested, 35 had detectable BLLs. Two questions from the questionnaire demonstrated significant differences in proportions (Fisher's exact test: P < .05) of affirmative/negative responses, for the 35 participants with detectable BLLs. CONCLUSION: The questionnaire failed to identify reliable associations between detectable BLLs and affirmative responses, limiting its use as an in-office tool. More research is recommended to identify and alleviate barriers to childhood lead screening in the clinical setting and to develop more applicable risk assessment tools.
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Exposição Ambiental/efeitos adversos , Intoxicação por Chumbo/diagnóstico , Chumbo/sangue , Programas de Rastreamento/estatística & dados numéricos , Inquéritos e Questionários , Algoritmos , Criança , Serviços de Saúde da Criança , Pré-Escolar , Feminino , Hospitais Universitários , Humanos , Lactente , Intoxicação por Chumbo/sangue , Intoxicação por Chumbo/prevenção & controle , Masculino , Nevada , Ambulatório Hospitalar , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Sensibilidade e EspecificidadeRESUMO
OBJECTIVE: To evaluate symptom improvement in 53 children (aged 5-11 years) with endoscopically proven gastroesophageal reflux disease (GERD) treated with pantoprazole (10, 20 and 40 mg) using the GERD Assessment of Symptoms in Pediatrics Questionnaire. METHODS: The GERD Assessment of Symptoms in Pediatrics Questionnaire was used to measure the frequency and severity over the previous 7 days of abdominal/belly pain, chest pain/heartburn, difficulty swallowing, nausea, vomiting/regurgitation, burping/belching, choking when eating and pain after eating. Individual symptom scores were based on the product of the frequency and usual severity of each symptom. The sum of the individual symptom score values made up the composite symptom score (CSS). The primary end point was the change in the mean CSS from baseline to week 8. RESULTS: Mean frequency and severity of each symptom significantly decreased (from P < 0.006 to P < 0.001) over time. Similar significant decreases in CSS at week 8 versus baseline (P < 0.001) were seen in all groups. Significant decreases from baseline in CSS were noted from weeks 1 to 8 in the 20-mg (P < 0.003) and 40-mg (P < 0.001) groups. The 20- and 40-mg doses were significantly (P < 0.05) more effective than the 10-mg dose in improving GERD symptoms at week 1. Adverse events were similar among the treatment groups. CONCLUSIONS: Pantoprazole (20 and 40 mg) is effective in reducing endoscopically proven GERD symptoms in children. Both 20 and 40 mg pantoprazole significantly reduced symptoms as early as 1 week.
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Antiulcerosos/uso terapêutico , Benzimidazóis/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Refluxo Gastroesofágico/patologia , Omeprazol/análogos & derivados , Sulfóxidos/uso terapêutico , 2-Piridinilmetilsulfinilbenzimidazóis , Antiulcerosos/efeitos adversos , Benzimidazóis/efeitos adversos , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Omeprazol/efeitos adversos , Omeprazol/uso terapêutico , Pantoprazol , Índice de Gravidade de Doença , Sulfóxidos/efeitos adversos , Inquéritos e Questionários , Fatores de Tempo , Resultado do TratamentoRESUMO
Two gastroesophageal reflux disease (GERD) symptom questionnaires were developed and tested prospectively in a pilot study conducted in infants (1 through 11 months) and young children (1 through 4 years) with and without a clinical diagnosis of GERD. A pediatric gastroenterologist made the clinical diagnosis of GERD. Parents or guardians at 4 study sites completed the questionnaires, providing information on the frequency and severity of symptoms appropriate to the 2 age cohorts. In infants, symptoms assessed were back arching, choking or gagging, hiccups, irritability, refusal to feed and vomiting or regurgitation. In young children, symptoms assessed were abdominal pain, burping or belching, choking when eating, difficulty swallowing, refusal to eat and vomiting or regurgitation. Respondents were asked to describe additional symptoms. Symptom frequency was the number of occurrences of each symptom in the 7 days before completion of the questionnaire. Symptom severity was rated from 1 (not at all severe) to 7 (most severe). An individual symptom score was calculated as the product of symptom frequency and severity scores. The composite symptom score was the sum of the individual symptom scores. The mean composite symptom and individual symptom scores were higher in infants (P<0.001 and P<0.05, respectively) and young children (P<0.001 and P<0.05, respectively) with GERD than controls. Vomiting/regurgitation was particularly prevalent in infants with GERD (90%). Both groups with GERD were more likely to experience greater severity of symptoms. We found the GERD Symptom Questionnaire useful in distinguishing infants and young children with symptomatic GERD from healthy children.