iKanEat: Protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol

Background Although tube feeding routinely saves the lives of children who do not eat by mouth, chronic tube feeding can be a burden to patients, caregivers, and families. Very few randomized trials exist regarding the best methods for weaning children from their feeding tubes. Methods The current paper describes a randomized controlled trial of an empirically supported outpatient treatment protocol for moving children from tube to oral eating called iKanEat. Specifically, we describe the methods of randomized double-blind, placebo-controlled trial which includes a 4-week course of megestrol, the only medication used in the iKanEat protocol, to determine whether the addition of megestrol results in improved child outcomes. The primary and secondary aims are to assess the safety and efficacy of megestrol as part of the iKanEat protocol. The third aim is to provide critical information about the impact of the transition from tube to oral feeding on parent stress and parent and child quality of life. Discussion This trial will provide data regarding whether megestrol is a safe and effective component of the iKanEat tube weaning protocol, as well as important data on how the tube weaning process impacts parent stress and parent and child quality of life

A Randomized Controlled Trial of an Outpatient Protocol for Transitioning Children from Tube to Oral Feeding: No Need for Amitriptyline.

ObjectiveTo assess the role of amitriptyline in the effectiveness of an outpatient protocol for weaning medically complicated children from tube to oral feeding.Study designTwenty-one children seen in multidisciplinary outpatient feeding teams across 4 sites were recruited to a randomized placebo-controlled trial of a 6-month outpatient treatment protocol with behavioral, oral-motor, nutrition, and medication components.ResultsAll of the children who completed the 6-month program (73%) were weaned to receive only oral feeding, regardless of group assignment. The transition from tube to oral feeding resulted in decreases in body mass index percentile and pain, some improvements in quality of life, and no statistically significant changes in cost.ConclusionsAmitriptyline is not a key component of this otherwise effective outpatient, interdisciplinary protocol for weaning children from tube to oral feeding.Trial registrationClinicalTrials.gov: NCT01206478

Is histologic esophagitis associated with dental erosion: a cross-sectional observational study?

Abstract Background Gastroesophageal reflux disease (GERD) affects 15–25% of children and adolescents in the United States. The diagnosis of GERD in children is complex as reported symptoms or symptom profiles have been found to be unreliable. Frequently, the diagnosis must be confirmed by objective tests such as pH monitoring or histological evidence of esophagitis on an esophageal biopsy. Dental erosion has been shown to be associated with GERD as an atypical complication and has the potential to be a marker of GERD. The purposes of this study were to compare the frequency and patterns of dental erosion in children and adolescents with and without histologic esophagitis. Methods Twenty-five subjects were recruited from patients scheduled for an upper gastrointestinal endoscopy. Information regarding potential GERD symptoms, food habits, and dental hygiene habits were obtained. Intra-oral photographs were taken, and a dental exam for erosion was performed. The results of a standard biopsy taken from the lower third of the esophagus during an endoscopy were used to divide subjects into either the control group or the GERD group (i.e. those with histologic esophagitis). Results Twenty-two subjects yielded 586 evaluable teeth. No significant difference was found between frequency or erosion patterns of those with and without histologic esophagitis. Dental erosions were more frequent in primary teeth. Conclusions Dental erosions do not appear to be associated with histologic esophagitis indicative of GERD

A comparison of the diagnosis of gastroparesis in 4 h pediatric gastric emptying studies versus 2 h studies

Abstract Background In adults, there is a consensus for standards to diagnose gastroparesis utilizing a gastric emptying study as the key diagnostic modality but there is no consensus for a standard in pediatrics. Additionally, some cost savings might be achieved if symptoms could be utilized to predict patients with gastroparesis. The aims of the current study were to confirm the sensitivity of a 4 h study in the pediatric population and to assess whether the severity of symptoms were predictive of delayed gastric emptying. Study This was a single site, two part study. In the first part, results were reviewed for all patients who had completed a 4-h, solid gastric emptying study over the course of a 3 year period. In the second portion of the study, participants scheduled for a gastric emptying study, completed a modified GCSI questionnaire. Results Out of a total of 109 participants, at 2 h, 14 participants (12.8%) had abnormal studies as compared to 26 (23.85%) participants who had abnormal studies at 4 h (p = .0027). Of the 95 participants with normal studies at 2 h, 15% (14/95) were abnormal at 4 h. There were no differences in symptom severity scores between those with slow and those with normal emptying at either 2 h or 4 h. Conclusions Our study adds independent confirmation that extending studies from 2 to 4 h increases the diagnostic yield and should be the standard in children and adolescents as it is in adults

Sleep problems and functional disability in children with functional gastrointestinal disorders: An examination of the potential mediating effects of physical and emotional symptoms

BACKGROUND: Sleep disturbances are increasingly recognized as a common problem for children and adolescents with chronic pain conditions, but little is known about the prevalence, type, and impact of sleep problems in pediatric functional gastrointestinal disorders (FGIDs). The objectives of the current study were two-fold: 1) to describe the pattern of sleep disturbances reported in a large sample of children and adolescents with FGIDs; and, 2) to explore the impact of sleep by examining the inter-relationships between sleep disturbance, physical symptoms, emotional problems, and functional disability in this population. METHODS: Over a 3-year period, 283 children aged 8–17 years who were diagnosed with an FGID and a primary caretaker independently completed questionnaires regarding sleep, emotional functioning, physical symptoms, and functional disability during an initial evaluation for chronic abdominal pain at a pediatric tertiary care center. A verbal review of systems also was collected at that time. Descriptive statistics were used to characterize the pattern of sleep disturbances reported, while structural equation modeling (SEM) was employed to test theorized meditational relationships between sleep and functional disability through physical and emotional symptoms. RESULTS: Clinically significant elevations in sleep problems were found in 45% of the sample, with difficulties related to sleep onset and maintenance being most common. No difference was seen by specific FGID or by sex, although adolescents were more likely to have sleep onset issues than younger children. Sleep problems were positively associated with functional disability and physical symptoms fully mediated this relationship. Emotional symptoms, while associated with sleep problems, evidenced no direct link to functional disability. CONCLUSIONS: Sleep problems are common in pediatric FGIDs and are associated with functional disability through their impact on physical symptoms. Treatments targeting sleep are likely to be beneficial in improving physical symptoms and, ultimately, daily function in pediatric FGIDs

Additional file 2: of Is histologic esophagitis associated with dental erosion: a cross-sectional observational study?

Food-Dental Care Questionnaire - The questionnaire evaluated the presence and frequency of specific dietary consumptions and dental hygiene habits. Diet and medication items assessed included between meal snacks, carbonated beverages, swishing and holding drinks in the mouth, fruit juices before bed, energy drinks, medicines in a syrup form, chewing Vitamin C tablets, asthma inhalers, citrus fruits, yogurt, and pickles. Oral hygiene and habit items included grinding teeth at night, tooth brushing in the morning, tooth brushing before going to bed, use of fluoride treatments, receiving regular dental care, presence of fluoride in drinking water, type of toothbrush, and frequency of brushing. (DOCX 23 kb

Multicenter, Randomized, Placebo-Controlled Trial of Amitriptyline in Children With Functional Gastrointestinal Disorders

There are no prospective, multicenter, double-blind, placebo-controlled, randomized pharmacologic trials for the treatment of pain-predominant functional gastrointestinal disorders in children. The aim of this study was to evaluate the efficacy of amitriptyline in children with pain-predominant functional gastrointestinal disorders. In this multicenter placebo-controlled trial, children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia were randomized to 4 weeks of placebo or amitriptyline (10 mg/d, weight 35 kg). Assessment of gastrointestinal symptoms, psychological traits, and daily activities occurred before and after intervention. Pain was assessed daily with self-report diaries. The primary outcome was overall response to treatment (child's assessment of pain relief and sense of improvement). Secondary outcomes were effect on psychosocial traits and daily functioning. Ninety children were enrolled, and 83 completed the study (placebo, 40 children [30 girls]; drug, 43 children [35 girls]). A total of 63% of patients reported feeling better and 5% feeling worse in the amitriptyline arm compared with 57.5% feeling better and 2.5% feeling worse in the placebo arm ( P = .63). Pain relief was excellent in 7% and good in 38% of children receiving placebo compared with excellent in 15% and good in 35% of children treated with amitriptyline ( P = .85). Logistic regression analysis of those reporting excellent or good response versus fair, poor, or failed response showed no difference between amitriptyline and placebo ( P = .83). Children who had more severe pain at baseline in both groups ( P = .0065) had worse outcome. Amitriptyline reduced anxiety scores ( P < .0001). Both amitriptyline and placebo were associated with excellent therapeutic response. There was no significant difference between amitriptyline and placebo after 4 weeks of treatment. Patients with mild to moderate intensity of pain responded better to treatment

Additional file 1: of Is histologic esophagitis associated with dental erosion: a cross-sectional observational study?

GERD Symptoms Questionnaire - The questionnaire assessed the presence of various symptoms and if present, the subjects rated severity on a 3-point Likert scale (mild, moderate, severe) and estimated episode frequency per week [17]. Symptoms included pain (in general and with consumption of fried and spicy foods), dysphagia, nausea, vomiting/regurgitation, chest pain, heartburn, excessive belching, bad breath, excessive crying, poor sleep, and relief from anti-acid medications. (DOC 62 kb