View clinical trials related to Enterocolitis.
Filter by:Food Protein-Induced Enterocolitis Syndrome (FPIES) is a non IgE-mediated allergy, presenting with vomiting, and may be complicated by hypovolemic shock. The pathophysiology of FPIES is not well characterized and there is no biological marker confirming the diagnosis or predicting recovery. Gut microbiota in IgE-mediated allergy is pro-inflammatory and the addition of pro- or prebiotics can accelerate healing. Microbiota of patients with FPIES have never been studied yet. The aim of this work is therefore to analyse longitudinally the gut microbiota of patients with FPIES, before and after healing, in order to predict the recovery from FPIES. The cutaneous and salivary microbiota will also be analysed at the same time, in order to look for a correlation between these three microbiota.
BACKGROUND Treatment of neonatal respiratory distress syndrome with exogenous surfactant and mechanical ventilation made millions of preterm infants survived in neonatal intensive care unit (NICU). Endotracheal intubation surfactant administration is related to invasive intubation and short periods of positive pressure ventilation and implies the risk of lung injury. Continuous positive airway pressure (CPAP) or NIPPV (Non-invasive positive pressure ventilation) with surfactant but without intubation may work synergistically. This randomized trial investigated a minimal invasive surfactant administration (MISA). To test the hypothesis that MISA increases survival without bronchopulmonary dysplasia (BPD) at 36 weeks' gestational age in very low birth weight infants. DESIGN, SETTING, AND PARTICIPANTS The Minimal Invasive Surfactant Administration (MISA) was a multicenter, randomized, clinical, parallel-group study conducted between July 1st, 2017, and November 30, 2018, in 8 level III neonatal intensive care units in Beijing, Tianjin, and Hebei province, China. The final follow-up date was March 30, 2019. Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. In an intention-to-treat design, infants were randomly assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) either via a 5Fr nasogastric tube during CPAP/NIPPV-assisted spontaneous breathing (minimal invasive surfactant administration group, MISA group) or after conventional endotracheal intubation during mechanical ventilation (endotracheal intubation surfactant administration group, EISA group). INTERVENTION MISA via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps.
This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation. We hypothesize that specific genetic factors and microbiome could predispose preterm neonates for the development of NEC.
In recent days, necrotizing enterocolitis is one of the most common and devastating problem in preterm infants. Therefore, it became a high growing research topic in the last decade. The development of medical care increases the survival of preterm babies and consequently increase the number of cases with this serious problem. A systematic review shows the incidence of necrotizing enterocolitis is about 2-7% in babies less than 32weeks gestation and 5-22% in baby's birth weight less than 1000gram.
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and infections. Early in life, premature babies must get aggressive nutrition so that there is no extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group compared to the non-IUGR group. Other factors that also play a role are long episodes of fasting, the fulfillment of nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI), duration of parenteral total administration, the incidence of respiratory distress syndrome and incidence of necrotizing enterocolitis. Zinc is one of the micronutrients which is very risky for deficiency in premature babies. Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who received zinc supplementation increased after being given 10 days of zinc supplementation and lower mortality rates in the group with supplementation. Very low birth weight babies and bronchopulmonary dysplasia who received zinc supplementation during the week showed good clinical progress and the growth rate also increased. The investigators believe this study has the potential for decreasing infant mortality from its current level and can be a growth indicator for preterm babies.
Background: Intestinal resections are commonly performed in the pediatric population. Perfusion of the bowel is one of the most important factors determining the viability of an intestinal anastomosis. Up to date, no ideal method to assess intestinal perfusion has proven its superiority. Objectives: Primary: The aim of this study is to establish the feasibility and impact of the use of indocyanine green technology on intestinal resection margins during elective and emergency pediatric surgeries. Secondary: The secondary outcomes of interest include collection of adverse events and difficulties encountered with the use of the indocyanine green (ICG) technology. Postoperative surgical complications will also be recorded. Study Design: An open observational clinical study will be performed by using a clinical drug (indocyanine green) and medical device (SPY Fluorescence Imaging) to assess intraoperatively intestinal perfusion in a specific pediatric population.
The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies. Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series/reports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy. Despite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Necrotizing enterocolitis (NEC) is a devastating disease affecting the intestines of premature infants. It involves intestine swelling, tissue destruction, infection, and even death. Improved outcome is highly dependent on early recognition and treatment, however the signs and symptoms of NEC in early stages are not obvious making it difficult to diagnose. Abdominal x-rays and ultrasound can be non-specific and may not show signs of the disease until late in its course. Infrared imaging is a non-invasive, non-radiation method that can measure the heat given off of the surface of the body and create heat maps. It is being used clinically in other situations but is still under investigation for use in preterm infants with suspected NEC. Computer analysis of the measured heat maps can be used to detect changes in the intestine such as the swelling or tissue destruction involved in NEC. Our group has previously performed a pilot study that showed that infrared imaging on babies in the NICU can be used to create heat maps that are different between normal babies and those with NEC when analyzed using specialized computer programs. In this study the investigators will improve the imaging process by using special vision sensors to automate the imaging process and make it easier for bedside staff to use this technology. Special programs will be developed to automatically select areas of interest over which temperature maps will be analyzed. The investigators will use this new imaging technique to study a population of newborns diagnosed with definitive NEC and a healthy population of newborns without NEC, and compare the heat maps obtained from each group. From the analysis of the images obtained from these two populations, the investigators will determine the suitability and necessary fine-tuning of this new imaging technique with the hopes that this technology can someday aid in the early diagnosis of NEC.
IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.